Home GUDID 16973774250012 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
Primary DI 16973774250012
Brand Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
Company Biohit Healthcare (Hefei) Co., Ltd.
Model 25 Tests/Kit
Catalog number REF:207.01.25.02
Published 2022-08-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QKO Reagent, Coronavirus Serological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QKO Reagent, Coronavirus Serological Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16973774250012 Package GS1 25 In Commercial Distribution 26973774250019 Package GS1 18 In Commercial Distribution 06973774250015 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16973774250012 16973774250012 26973774250019 26973774250019 06973774250015 06973774250015 6973774250015
GMDN Terms# Term, Definition table Term Definition SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 560014279 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06973774259803 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 25 Tests/Kit REF:207.01.25.02 2022-08-16
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06972412619405 Lyher Hangzhou Laihe Biotech Co.,Ltd. QKO 2024-11-11 00816870023557 SARS-CoV-2 IgA AccuBind ELISA Test System - 96 Wells MONOBIND, INC. QKO 2024-09-13 00816870023564 SARS-CoV-2 IgA AccuBind ELISA Test System - 192 Wells MONOBIND, INC. QKO 2024-09-13 00816870023595 SARS-CoV-2 IgG AccuBind ELISA Test System - 96 Wells MONOBIND, INC. QKO 2024-09-13 00816870023601 SARS-CoV-2 IgG AccuBind ELISA Test System - 192 Wells MONOBIND, INC. QKO 2024-09-13 00816870023632 SARS-CoV-2 IgM AccuBind ELISA Test System - 96 Wells MONOBIND, INC. QKO 2024-09-13 00816870023649 SARS-CoV-2 IgM AccuBind ELISA Test System - 192 Wells MONOBIND, INC. QKO 2024-09-13 00816870024868 SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 Wells MONOBIND, INC. QKO 2024-09-13 00816870024875 SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells MONOBIND, INC. QKO 2024-09-13 10758750035465 VITROS ORTHO CLINICAL DIAGNOSTICS QKO 2023-11-22 20758750035462 VITROS ORTHO CLINICAL DIAGNOSTICS QKO 2023-11-22 03610522220519 Platelia BIO-RAD QKO 2023-07-03 03610522220526 Platelia BIO-RAD QKO 2023-07-03 B379COVEG1 SCoV-2 Detect™ IgG ELISA INBIOS INTERNATIONAL, INC QKO 2022-12-08 B379COVEM1 SCoV-2 Detect™ IgM ELISA INBIOS INTERNATIONAL, INC QKO 2022-12-08 B379COVGRE1 SCoV-2 Detect™ IgG Rapid Test INBIOS INTERNATIONAL, INC QKO 2022-12-08 B379COVNE1 SCoV-2 Detect™ Neutralizing Ab ELISA INBIOS INTERNATIONAL, INC QKO 2022-12-08 06973774259803 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit Biohit Healthcare (Hefei) Co., Ltd. QKO 2022-08-16 15099590738617 Access SARS-CoV-2 IgM Beckman Coulter, Inc. QKO 2022-05-04 15099590738624 Access SARS-CoV-2 IgM Calibrator Beckman Coulter, Inc. QKO 2022-05-04 15099590738631 Access SARS-CoV-2 IgM QC Beckman Coulter, Inc. QKO 2022-05-04 15099590738648 Access SARS-CoV-2 IgG Beckman Coulter, Inc. QKO 2022-05-04 15099590738655 Access SARS-CoV-2 IgG Calibrator Beckman Coulter, Inc. QKO 2022-05-04 15099590738662 Access SARS-CoV-2 IgG QC Beckman Coulter, Inc. QKO 2022-05-04 15099590742744 Access SARS-CoV-2 IgG II Beckman Coulter, Inc. QKO 2022-05-04 15099590742751 Access SARS-CoV-2 IgG II Calibrator Beckman Coulter, Inc. QKO 2022-05-04 15099590742768 Access SARS-CoV-2 IgG II QC Beckman Coulter, Inc. QKO 2022-05-04 10758750034413 VITROS ORTHO CLINICAL DIAGNOSTICS QKO 2021-11-08 10758750034420 VITROS ORTHO CLINICAL DIAGNOSTICS QKO 2021-11-08 10758750034567 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. QKO 2021-11-08