FDA.reportPublic FDA data

Fastep COVID-19 IgG/IgM Rapid Test Device

Primary DI
06952804805029
Brand
Fastep COVID-19 IgG/IgM Rapid Test Device
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
QKOReagent, Coronavirus Serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKOReagent, Coronavirus SerologicalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952804805029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804805029069528048050296952804805029

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses to aid the diagnosis of coronavirus disease (COVID-19) infection. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530757741
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26952804809700Multi-dip Drugs Test (BZO 300 Dip Card)1.02026-02-10
16952804808324Multi-Panel Drug Test Cup1.02025-03-18
26952804810461Marijuana Test Strip1.02025-03-18
06952804801175Methamphetamine Strip1.02017-02-06
06952804801182Phencyclidine Strip1.02017-02-06
06952804801199Marijuana Strip1.02017-02-06
06952804801458Methamphetamine/Phencyclidine/Marijuana Panel Dip1.02017-02-07
06952804801465Methamphetamine/Phencyclidine/Marijuana Quick Cup1.02017-02-07
06952804801472Methamphetamine/Phencyclidine/Marijuana Turnkey Split Cup1.02017-02-07
06952804801779Methamphetamine Panel Dip1.02017-07-24
06952804801786Phencyclidine Panel Dip1.02017-07-24
06952804801793Marijuana Panel Dip1.02017-07-24
06952804802608AssureTech Panel Dip Tests1.02018-09-04
06952804802615AssureTech Quick Cup Tests1.02018-09-04
06952804802622AssureTech Panel Dip Tests1.02018-09-04
06952804802639AssureTech Quick Cup Tests1.02018-09-04
06952804801090hCG Pregnancy Test Cassette1.02016-09-24
06952804801205hCG Pregnancy Serum/Urine Combo Test Cassette1.0HCG-C232017-02-04
06952804801212HCG Pregnancy Test Strip1.02016-09-24
06952804801830hCG Pregnancy Serum/Urine Combo Test Strip(10/20)1.02017-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972412619405LyherHangzhou Laihe Biotech Co.,Ltd.QKO2024-11-11
00816870023557SARS-CoV-2 IgA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023564SARS-CoV-2 IgA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023595SARS-CoV-2 IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023601SARS-CoV-2 IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023632SARS-CoV-2 IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023649SARS-CoV-2 IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870024868SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870024875SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
10758750035465VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
20758750035462VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
03610522220519PlateliaBIO-RADQKO2023-07-03
03610522220526PlateliaBIO-RADQKO2023-07-03
B379COVEG1SCoV-2 Detect™ IgG ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
06973774259803Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.QKO2022-08-16
16973774250012Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.QKO2022-08-16
15099590738617Access SARS-CoV-2 IgMBeckman Coulter, Inc.QKO2022-05-04
15099590738624Access SARS-CoV-2 IgM CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590738631Access SARS-CoV-2 IgM QCBeckman Coulter, Inc.QKO2022-05-04
15099590738648Access SARS-CoV-2 IgGBeckman Coulter, Inc.QKO2022-05-04
15099590738655Access SARS-CoV-2 IgG CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590738662Access SARS-CoV-2 IgG QCBeckman Coulter, Inc.QKO2022-05-04
15099590742744Access SARS-CoV-2 IgG IIBeckman Coulter, Inc.QKO2022-05-04
15099590742751Access SARS-CoV-2 IgG II CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590742768Access SARS-CoV-2 IgG II QCBeckman Coulter, Inc.QKO2022-05-04
10758750034413VITROSORTHO CLINICAL DIAGNOSTICSQKO2021-11-08
10758750034420VITROSORTHO CLINICAL DIAGNOSTICSQKO2021-11-08