(C) ProPublica.
This unaltered story was originally published at ProPublica.org. [1]
Licensed under creative commons by-nc-nd/3.0 [2]
Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2
Author Name, ProPublica
2021-10-29 16:04:00
Anhui Deepblue Medical Technology Co., Ltd. COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
Artron BioResearch Inc./ Artron Laboratories Inc. COVID-19 IgM/IgG Antibody Test Removed - Should Not Be Distributed*
BestNovo (Jiangsu) Medical Technology Co., Ltd. BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit Removed - Should Not Be Distributed
Biobase Biodustry (Shandong) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
BioMedomics, Inc. COVID-19 IgM-IgG rapid test Removed - Should Not Be Distributed*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody Removed - Should Not Be Distributed
Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody Removed - Should Not Be Distributed
Pure Genetic Medical Ltd. (Distributed Boson Biotech Ltd. Co) Rapid 2019-nCoV IgG/IgM Combo Test Card Removed - Should Not Be Distributed
Changchun Wancheng Bio-Electron Co., Ltd. COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) Removed - Should Not Be Distributed
Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test Removed - Should Not Be Distributed*
Genlantis Diagnostics, Inc. CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test Removed - Should Not Be Distributed*
Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette Removed - Should Not Be Distributed
Hangzhou Testsea Biotechnology Co., Ltd. One Step SARS-CoV2(COVID-19) IgG/IgM Test Removed - Should Not Be Distributed*
Hunan RunKun Pharmaceutical Co., Ltd. SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Jiangsu Eubo Biotechnology Co., Ltd. EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) Removed - Should Not Be Distributed
Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay Removed - Should Not Be Distributed
Phamatech COVID19 IgG / IgM Rapid Test Removed - Should Not Be Distributed*
Promedical COVID-19 Rapid Test Removed - Should Not Be Distributed
Saladax Biomedical COVID-19 IgG/IgM Rapid Antibody Test Removed - Should Not Be Distributed*
Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test Removed - Should Not Be Distributed
Shenzen Landwind Medical Co., Ltd. COVID-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed*
VITA Testing COVID-19 IgM/IgG Antibody Rapid Test Kit Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit Removed - Should Not Be Distributed
Zhongshan Bio-Tech Co Ltd. SARS-CoV-2 IgM/IgG (GICA) Removed - Should Not Be Distributed*
Zhuhai Encode Medical Engineering Co., Ltd Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device Removed - Should Not Be Distributed*
IMMY, Inc. clarus SARS-CoV-2 Total Antibody EIA Removed - Should Not Be Distributed*
Beijing Decombio Biotechnology Co., Ltd. Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood) Removed - Should Not Be Distributed*
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit Removed - Should Not Be Distributed
Tianjin Beroni Biotechnology Co. Ltd SARS-CoV-2 IgG/IgM Antibody Detection Kit Removed - Should Not Be Distributed
Calbiotech, Inc. ErbaLisa® COVID-19 IgG Removed - Should Not Be Distributed
ACCOBiotech SDN.BHD ACCO COVID-19 IgM/IgG TEST Removed - Should Not Be Distributed
Innovation Biotech (Beijing) Co., Ltd. SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method) Removed - Should Not Be Distributed
W.H.P.M., Inc. COVID-19 IgM/IgG Rapid Test Removed - Should Not Be Distributed
W.H.P.M., Inc. COVISURE™ COVID-19 IgM/IgG Rapid Test Removed - Should Not Be Distributed
Sure Bio-tech API Covid-Rapid IgM/IgG Antibody Test Kit Removed - Should Not Be Distributed
Nantong Egens Biotechnology Co., Ltd EGENS COVID-19 IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
Suzhou Kangheshun Medical Technology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed
Aurora Biomed Inc. COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold) Removed - Should Not Be Distributed
Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System Removed - Should Not Be Distributed
Getein Biotech Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) Removed - Should Not Be Distributed
Guangdong Hecin Scientific, Inc. SARS-CoV-2 IgM Antibody Rapid Test Kit Removed - Should Not Be Distributed*
Fosun Pharma USA Inc. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit Removed - Should Not Be Distributed*
Atlas Link (Beijing)Technology Co., Ltd NovaTest: One Step COVID-19 IgG/IgM rapid test Removed - Should Not Be Distributed
SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo Removed - Should Not Be Distributed
Audacia Bioscience CMC-19D SARS-CoV2 (COVID-19) Rapid Antibody Test Removed - Should Not Be Distributed
JOYSBIO (Tianjin) Biotechnology Co., Ltd. COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
BioSys Laboratories, Inc. BioSys Plus COVID-19 IgM/IgG Rapid Test Removed - Should Not Be Distributed
ICT international 2019-nCoV IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed*
One Milo, Inc. InstantRapid® SARS CoV-2 IgG IgM Test Removed - Should Not Be Distributed
Nanjing Vazyme Medical Technology Co., LTD. 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) Removed - Should Not Be Distributed*
Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold) Removed - Should Not Be Distributed*
Alfa Scientific Designs, Inc. Clarity COVID-19 IgG/IgM Antibody Test Removed - Should Not Be Distributed
Alfa Scientific Designs, Inc. Instant-view plus COVID-19 IgG/IgM Antibody Test Removed - Should Not Be Distributed
Biolidics Limited 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Guangzhou Fenghua Bioengineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test Removed - Should Not Be Distributed
Guangzhou Decheng biotechnology DOCHEK™ SARS-CoV-2 Antibody Rapid Test Kit Removed - Should Not Be Distributed*
Biomerica, Inc. COVID-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed
Safecare Biotech (Hagzhou) Co., Ltd. SAFECARE COVID-19 IgG/IgM Rapid Test Device Removed - Should Not Be Distributed
RayBiotech Life, Inc. Novel Coronavirus (SARS-CoV-2) IgM and IgG Antibody Detection Kits for Serum Removed - Should Not Be Distributed
RayBiotech Life, Inc. Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit for Serum Removed - Should Not Be Distributed
Abbexa Ltd abx294171 - COVID-19 IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
H-Guard (China) Co., Ltd. Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) Removed - Should Not Be Distributed*
Vivera Pharmaceuticals, Inc. Vivera Pharma COVID-19 Rapid Test Removed - Should Not Be Distributed*
Lepu Medical Technology (Beijing) Co., Ltd. Lepu SARS-CoV-2 Antibody Rapid Test Removed - Should Not Be Distributed
Camtech Diagnostics Pte Ltd Camtech Covid-19 IgM/IgG 2C Rapid Test Removed - Should Not Be Distributed
Camtech Diagnostics Pte Ltd Camtech Covid-19 IgM/IgG 1C Rapid Test Removed - Should Not Be Distributed
Discount Diagnostics Global WholeHealth Partners RDT IgG/IgM Antibody test Removed - Should Not Be Distributed
GenBody Inc. GenBody COVID-19 IgM/IgG Removed - Should Not Be Distributed
Invenio Medical COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) Removed - Should Not Be Distributed
Invenio Medical COVID-19 IgG/IgM Ab Rapid Test Removed - Should Not Be Distributed
Pinnacle Biolabs SARS-CoV-2 IgG/IgM Rapid Test Removed - Should Not Be Distributed
Universal Meditech Inc. DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test Removed - Should Not Be Distributed
Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit Removed - Should Not Be Distributed
Edinburgh Genetics Limited ActivXpress+ COVID-19 IgG/IgM Immunoassay Complete Testing Kit Removed - Should Not Be Distributed*
Sure Bio-Tech API Pharma Covid-Rapid IgM/IgG Antibody Test Removed - Should Not Be Distributed
Tianjin New Bay Bioresearch Co., Ltd. Quikpac II COVID-19 IgG/IgM Removed - Should Not Be Distributed*
Boston Biopharma Inc. BB Rapid-MT Removed - Should Not Be Distributed*
Wuhan EasyDiagnosis Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Removed - Should Not Be Distributed
Leritas LLC DualTec SARS-CoV-2 Test Kit Removed - Should Not Be Distributed*
PCL Inc. COVID19 IgG/IgM Rapid Gold Removed - Should Not Be Distributed
Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG Removed - Should Not Be Distributed*
NanoEntek, Inc. FREND COVID-19 IgG/IgM Duo Removed - Should Not Be Distributed*
Naturitious LLC Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT Removed - Should Not Be Distributed*
Jiangsu Dablood Pharmaceutical Co. Ltd. COVID-19 IgM/IgG Rapid Test Removed - Should Not Be Distributed
Xiamen AmonMed Biotechnology Co., Ltd. Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
Genobio Pharmaceutical Co., Ltd. COVID-19 IgM/IgG Lateral Flow Assay Removed - Should Not Be Distributed*
Arbor Vita Corporation CoVisa IgG Test Removed - Should Not Be Distributed
Shanghai Outdo Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test Removed - Should Not Be Distributed*
ZEUS Scientific, Inc. ZEUS Rapid SARS-CoV-2 IgM/IgG Test System Removed - Should Not Be Distributed*
Autobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test Removed - Should Not Be Distributed
Beijing DiaGreat Biotechnologies Co. Ltd. 2019-nCoV IgM Antibody Determination Kit Removed - Should Not Be Distributed*
Beijing DiaGreat Biotechnologies Co. Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit Removed - Should Not Be Distributed*
Beijing DiaGreat Biotechnologies Co. Ltd. 2019-nCoV IgG Antibody Determination Kit Removed - Should Not Be Distributed*
Chemtron Biotech, Inc. Chemtrue®Rapid COVID-19 IgM/IgG Antibody Test Removed - Should Not Be Distributed
Asan Pharmaceutical Co., Ltd. Asan Easy Test COVID-19 IgG/IgM Removed - Should Not Be Distributed*
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Shanghai Fosun Long March Medical Science Co., Ltd. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit Removed - Should Not Be Distributed*
GREEN ENERGY TECHNOLOGY SOLUTIONS, LLC AMP Rapid Test SARS-CoV-2 IgG/IgM Removed - Should Not Be Distributed*
Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test Removed - Should Not Be Distributed
Vitro Diagnostics Vitro Diagnostics COVID 19 IgG/IgM Rapid Test Cassette Serology Device Removed - Should Not Be Distributed
Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test Removed - Should Not Be Distributed*
Melbourne Biotech MB COVID-19 Antibody Detection Kit Removed - Should Not Be Distributed
Wuhu 3H Biotechnology Co. Ltd. COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) Removed - Should Not Be Distributed
Shijiazhuang Hipro Biotechnology Co., Ltd. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
Sinocare, Inc. SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method) Removed - Should Not Be Distributed
Antibody BioPharm, Inc. COVID-19 IgM/IgG POCT Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Axium BioResearch, Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test Removed - Should Not Be Distributed*
PerGrande BioTech Development Co., Ltd. SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) Removed - Should Not Be Distributed*
Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit Removed - Should Not Be Distributed
Pacific Connect Group LLC (US) SARS-CoV-2 IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
Sober Holdings, LLC ProMed Rapid Testing - COVID-19 IgG/IgM Test Kit Removed - Should Not Be Distributed
Arbor Assays DetectX SARS-CoV-2 IgG ELISA Kit Removed - Should Not Be Distributed*
TM Testing, Inc. TM Test Kits, CoVID-19 Rapid Antibody Serology Test Removed - Should Not Be Distributed
Genesprint Group, Ltd. Genesprint Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 test Removed - Should Not Be Distributed*
Reszon Diagnostics International Sdn. Bhd. RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test Removed - Should Not Be Distributed*
Reszon Diagnostics International Sdn. Bhd. Reszon COVID-19 Rapid IgG/IgM Test Removed - Should Not Be Distributed*
Sober Holdings, LLC ProMed Rapid Test Removed - Should Not Be Distributed
Zalgen Labs, LLC. ReSARS CoV-2 (N) IgG ELISA Removed - Should Not Be Distributed*
Nanjing Weiyun Biotechnology Co., Ltd. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) Removed - Should Not Be Distributed
Zhuhai Keyu Biological Engineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
LumiQuick Diagnostics, Inc. QuickProfile™ 2019-nCoV IgG/IgM Antibody Test Removed - Should Not Be Distributed
MedicalSystem Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit Removed - Should Not Be Distributed*
GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit Removed - Should Not Be Distributed
Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test Removed - Should Not Be Distributed
Shenzhen Lvshiyuan Biotechnology Co., Ltd COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit Removed - Should Not Be Distributed
Sensing Self Pte. Ltd. COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit Removed - Should Not Be Distributed
EpiGentek SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit Removed - Should Not Be Distributed*
CoreMedica Laboratories, Inc. Capillary Blood Collection Kit & Laboratory Analysis for SARS-CoV-2 ELISA IgG and IgM Removed - Should Not Be Distributed
Oncosem Onkolojik Sistemler San.ve Tic. A.S CRT (COVID-19 Rapid Test) Removed - Should Not Be Distributed*
TheraTest Laboratories, Inc. EL-Anti-SARS-CoV-2 IgG Removed - Should Not Be Distributed*
Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay Removed - Should Not Be Distributed*
ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM Removed - Should Not Be Distributed*
BreviTest Technologies, LLC Brevitest SARS-CoV-2 IgG Test Removed - Should Not Be Distributed*
Cell ID Pte Ltd Smart COVID-19 IgM/IgG Rapid Diagnostic Test (RDT) Removed - Should Not Be Distributed*
Profarma, UAB ProRapid Coronavirus Disease (SARS-CoV-2) IgG/IgM Rapid Test Cassette Single Use Kit Removed - Should Not Be Distributed
EACHY Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay) Removed - Should Not Be Distributed
EACHY Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) Removed - Should Not Be Distributed
Xiamen Wiz Biotech Co., Ltd. Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Removed - Should Not Be Distributed
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) Removed - Should Not Be Distributed*
EACHY Biopharmaceuticals Co., Ltd. SmartScreen COVID-19 IgM/IgG Test Kit Removed - Should Not Be Distributed
AngelWorld Biotech Manufacturing FZ LLC AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Novel Coronavirus (2019-nCoV) Antibody Rapid Test Removed - Should Not Be Distributed
ScheBo® • Biotech AG ScheBo® SARS-CoV-2 Quick Removed - Should Not Be Distributed*
Newscen Coast Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic Combo Test Removed - Should Not Be Distributed
Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) Removed - Should Not Be Distributed
Accel Diagnostics, LLC Rapid C2T Total Ab (IgG/IgM) Card Removed - Should Not Be Distributed*
ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test Removed - Should Not Be Distributed
CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed
BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette Removed - Should Not Be Distributed*
Absology Co., Ltd. Absoludy COVID-19 IgM/IgG Combo Removed - Should Not Be Distributed*
Akston Biosciences Corporation AntiCoV-ID IgG ELISA Test Removed - Should Not Be Distributed
Epitope Diagnostics, Inc. EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit Removed - Should Not Be Distributed
Plexense, Inc. ACCEL ELISA COVID-19 Removed - Should Not Be Distributed*
Vivera Pharmaceuticals, Inc. COVx-RT Removed - Should Not Be Distributed
Absology Co., Ltd. Absoludy COVID-19 IgM/IgG RAPID Removed - Should Not Be Distributed*
Absology Co., Ltd. INIST COVID-19 IgM/IgG RAPID Removed - Should Not Be Distributed*
Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold Removed - Should Not Be Distributed*
Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed
Hangzhou AllTest Biotech Co., Ltd. AllTest COVID-19 IgG/IgM Rapid Test Strip Removed - Should Not Be Distributed
Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test Removed - Should Not Be Distributed*
Sunbeam Laboratories, LLC. Sunbeam Laboratories Covid-19 Rapid Test Kit Removed - Should Not Be Distributed*
Ansh Labs SARS-CoV2 IgG ELISA (AL-1001) Removed - Should Not Be Distributed
Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit Removed - Should Not Be Distributed*
Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit Removed - Should Not Be Distributed*
Xiamen AmonMed Biotechnology Co., Ltd. COVID-19 IgM/IgG test kit (Colloidal Gold) Removed - Should Not Be Distributed*
DNALink, Inc. AccuFind COVID19 IgG Removed - Should Not Be Distributed*
Spartacus-Biomed LFA COVID-19 IgG & IgM Rapid Test Device Removed - Should Not Be Distributed
Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed
Promedical Equipment Pty Ltd Promedical IgM/IgG Rapid Detection Kit Removed - Should Not Be Distributed
Nanjing Norman Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Boston Bio Lab Inc. Boston Bio EZ Covid-19 Removed - Should Not Be Distributed*
Bloom Diagnostics AG Bloom COVID-19 Test Removed - Should Not Be Distributed*
Victory Square Health, Inc. Safetest Covid-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed*
Wuhan UNscience Biotechnology Co., Ltd. Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography) Removed - Should Not Be Distributed*
Multi-G bvba COVID-19 IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed*
ClearSign Diagnostics Co., LLC ClearSign Diagnostics SARS-CoV-2 Antibody (IgM and IgG) Test Removed - Should Not Be Distributed
Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test Removed - Should Not Be Distributed
Alpha Pharma Service srl IRIS SARS-CoV-2 IgG/IgM Rapid Test Removed - Should Not Be Distributed
Global Go (Distributed Core Technology Co., Ltd.) RapidTest COVID-19 IgM/IgG Ab Test Removed - Should Not Be Distributed
NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test Removed - Should Not Be Distributed
Singuway Biotech Inc. COVID-19 IgG/IgM Detection Kit (Colloidal Gold) Removed - Should Not Be Distributed
VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test Removed - Should Not Be Distributed
Diabetomics, Inc CovAbScreen™ SARS-CoV-2 Ab Test Removed - Should Not Be Distributed*
Dynamiker Biotechnology (Tianjin) Co., Ltd. RapidCOV™ 2019-nCOV IgG/IgM Rapid Test Removed - Should Not Be Distributed
Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit Removed - Should Not Be Distributed*
Otogenetics OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection test Removed - Should Not Be Distributed*
Bioscience Diagnostic Technology Company Ltd. Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody Removed - Should Not Be Distributed
Bioscience Diagnostic Technology Company Ltd. Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody Removed - Should Not Be Distributed
DIALAB(ZJG) Biotech Co., Ltd. SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay) Removed - Should Not Be Distributed*
H&Z Life Science Co. Ltd. Anti-COVID-19 Virus IgM/IgG Test Kit (lateral flow assay) Removed - Should Not Be Distributed
Aegis Sciences Corporation SARS-CoV-2 Antibody, IgG assay Removed - Should Not Be Distributed*
Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method Removed - Should Not Be Distributed*
Newscen Coast Bio-Pharmaceutical Co., Ltd. COVID-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed
ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay Removed - Should Not Be Distributed*
Mokobio Biotechnology R&D Center Inc COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay) Removed - Should Not Be Distributed*
Sciteck Diagnostics COVID19 Automated Antibody Assay Removed - Should Not Be Distributed
VicTorch Meditek Inc. COVID-19 Serology IgM ELISA Removed - Should Not Be Distributed*
VicTorch Meditek Inc. COVID-19 Serology IgG ELISA Removed - Should Not Be Distributed*
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 NP IgG Removed - Should Not Be Distributed*
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 NP IgM Removed - Should Not Be Distributed*
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 S1 IgM Removed - Should Not Be Distributed*
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 S1 IgG Removed - Should Not Be Distributed*
MedMira Inc. REVEALCOVID-19™ Total Antibody Test Removed - Should Not Be Distributed*
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold) Removed - Should Not Be Distributed*
Pellecome LLC (Distributed Core Technology Co., Ltd.) CoreTest COVID-19 IgM/IgG Ab Test Removed - Should Not Be Distributed
Abingdon Health Ltd. AbC-19™ Rapid Test Removed - Should Not Be Distributed*
Horizon Pharmaceuticals, Inc. Horizon RDT SARS CoV-2 IgM/IgG Antibody Test Removed - Should Not Be Distributed
Nanjing SYNTHGENE Medical Technology Co., Ltd. SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method) Removed - Should Not Be Distributed
Ring Biotechnology Co Ltd COVID-19 IgM/IgG Rapid Test Kit Removed - Should Not Be Distributed*
Top Biotech Sdn. Bhd TOP RAPID COVID-19 Rapid Antibody IgG/IgM Test Kit Removed - Should Not Be Distributed
Gold Standard Diagnostics INgezim® COVID 19 CROM Rapid Test Kit Removed - Should Not Be Distributed*
Gold Standard Diagnostics INgezim® COVID 19 DR ELISA Test Kit Removed - Should Not Be Distributed*
Iontox COVID-19 (SARS-CoV-2) IgG antibody test kit Removed - Should Not Be Distributed*
Truvian Sciences Inc. Easy Check COVID-19 IgM/IgG™ POC Antibody Test Removed - Should Not Be Distributed*
Velox Biosystems COVID-19 Microarray IgG Immunoassay Removed - Should Not Be Distributed*
Hangzhou Sejoy Electronics & Instrument Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette Removed - Should Not Be Distributed*
VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette Removed - Should Not Be Distributed*
Victory Square Health Canada, Inc. Safetest-COVID19 IgG / IgM - Elisa Kit Removed - Should Not Be Distributed*
Bethyl Laboratories, Inc. Bethyl SARS-CoV-2 IgG IVD ELISA Removed - Should Not Be Distributed*
Spring Health Care AG COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Removed - Should Not Be Distributed
BioSure (UK) Limited BioSURE COVID-19 Antibody Rapid Test (REF: 92001COV) Removed - Should Not Be Distributed*
Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Rapid Test Removed - Should Not Be Distributed
Shandong ThinkLab Biotechnology Co., Ltd. 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay) Removed - Should Not Be Distributed
Antagen Pharmaceuticals, Inc. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold) Removed - Should Not Be Distributed*
AnyGo Technology Co., Ltd COVID-19 Capture ELISA Assay Removed - Should Not Be Distributed*
Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM kit Removed - Should Not Be Distributed*
Genabio LLC SARS-CoV-2 IgM/IgG (GICA) Test Removed - Should Not Be Distributed
Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method) Removed - Should Not Be Distributed
One Lambda, Inc. LABScreen™ COVID Plus Removed - Should Not Be Distributed*
Shenzhen Kingfocus Biomedical Engineering Co., Ltd. True-Dot™ Novel Coronavirus (2019-nCoV) IgM/IgG Rapid Antibody Detection Kit (Quantum Dot Immunochromatography) Removed - Should Not Be Distributed*
DxGen Corp. Epithod616 COVID-19 IgG Test Kit Removed - Should Not Be Distributed*
DxGen Corp. EDGC RapidCheck COVID-19 IgG Test Kit Removed - Should Not Be Distributed*
SA Scientific SAS™ COVID-19 Antibody Detection test Removed - Should Not Be Distributed*
Nanomix, Inc. Nanomix eLab® COVID-19 Rapid IgG/IgM Panel Removed - Should Not Be Distributed*
Pharmact GmbH BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test) Removed - Should Not Be Distributed*
Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) Removed - Should Not Be Distributed
SUREDX V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit Removed - Should Not Be Distributed
Shanghai Liangrun Biomedicine Technology Co., Ltd. Liangrun COVID-19 IgM/IgG Antibody Test Removed - Should Not Be Distributed
ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA Removed - Should Not Be Distributed*
ALPCO SARS-CoV-2 IgG ELISA Removed - Should Not Be Distributed*
ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA Removed - Should Not Be Distributed*
ALPCO SARS-CoV-2 IgM ELISA Removed - Should Not Be Distributed*
Medicon Company Limited Trueline COVID-19 IgG/IgM Rapid Test Removed - Should Not Be Distributed
Beijing O&D BIOTECH Co., LTD. Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold) Removed - Should Not Be Distributed
Molecular Innovations SARS-CoV-2 IgG Seroconversion ELISA Kit Removed - Should Not Be Distributed*
Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) Removed - Should Not Be Distributed
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Strip Format) Removed - Should Not Be Distributed*
VirIntel, LLC VirIntel COVID-19 Antibody Test Removed - Should Not Be Distributed
South Jersey Diagnostics, LLC COVID-19-CHECK-1 Removed - Should Not Be Distributed*
Zepto Life Technology ZepMIA20 SARS-CoV-2 IgG assay Removed - Should Not Be Distributed*
DLS Research & Ventures SCOV Immune Response Test Removed - Should Not Be Distributed
DLS Research & Ventures Screen For Coronaviruses (SCOV) Immune Response Test Removed - Should Not Be Distributed
DLS Research & Ventures Screen For Coronaviruses (SCOV) Test Removed - Should Not Be Distributed
Leinco Technologies, Inc. COVID-19 ImmunoRank Neutralization MICRO-ELISA Removed - Should Not Be Distributed
Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay Removed - Should Not Be Distributed*
Beacon Analytical Systems, Inc. SARS-CoV-2 Human IgG Antibody Test 96-Well Microtiter Plate Kit Format Removed - Should Not Be Distributed*
ProGnosis Biotech SA Bio-Shield 2019-nCoV Total Ig ELISA Removed - Should Not Be Distributed*
General Biologicals Corporation GB SARS-CoV-2 Ab ELISA, Cat. No.:4ECO001 Removed - Should Not Be Distributed*
Agilent Technologies, Inc Agilent Dako SARS-CoV-2 IgG ELISA kit Removed - Should Not Be Distributed*
Newscen Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic IgG/IgM Test Removed - Should Not Be Distributed
Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test Removed - Should Not Be Distributed
[END]
[1] URL:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
[2] URL:
https://creativecommons.org/licenses/by-nc-nd/3.0/us/
URL:
https://www.propublica.org/steal-our-stories
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gopher://magical.fish/1/feeds/news/propublica/
