FDA.reportPublic FDA data

FastPack SARS-CoV-2 IgG

Primary DI
00816467020389
Brand
FastPack SARS-CoV-2 IgG
Company
QUALIGEN INC.
Model
SARS-CoV-2 IgG Immunoassay
Catalog number
25000085
Device description
90 Test Kit SARS-CoV-2 IgG Immunoassay
Published
2020-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10816467020386PrimaryGS10
00816467020389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081646702038610816467020386
00816467020389008164670203898164670203890816467020389

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
959103565
Device count
90
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00816467020396FastPack® IP SystemIP System08000043-A, 08000043-AR2024-09-27
00816467020402FastPack® IP SystemIP System08000043-X22024-09-27
10816467020126FastPack® IP hCG Kit (30)hCG Immunoassay250000442016-09-16
00816467020105Calibrator Kit – hCGhCG Cal250000352016-09-16
00816467020112FastPack® IP hCG Diluent Kit (25)hCG Diluent250000362016-09-16
10816467020034FastPack® Testo Kit (50)Testo Immunoassay250000092016-09-16
20816467020031FastPack® IP Testo Kit (30)Testo Immunoassay250000412016-09-16
30816467020038FastPack® IP Testo Kit (90)Testo Immunoassay250000582017-09-14
00816467020044Calibrator Kit - TestosteroneTesto Cal250000142016-09-16
00816467020136FastPack® Control KitMulti-Analyte Controls250000562016-09-16
00816467020372FastPack® Pro System Pro System08000067, 08000067-R, 08000067-X2020-08-05
00816467020006FastPack® IP SystemIP System08000043, 08000043-R, 08000043-X2016-09-16
00816467020334FastPack® IP SystemIP System08000043-C, 08000043-CR2016-09-16
10816467020386FastPack SARS-CoV-2 IgGSARS-CoV-2 IgG Immunoassay250000852020-08-05
10816467020010FastPack® Total PSA Kit (50)TPSA Immunoassay250000012016-09-16
20816467020017FastPack® IP Total PSA Kit (30)TPSA Immunoassay250000402016-09-16
30816467020014FastPack® IP Total PSA Kit (90)TPSA Immunoassay250000572017-09-14
00816467020020Calibrator Kit - PSATPSA Cal250000022016-09-16
00816467020075Method Verification Kit - PSATPSA Verifier250000172016-09-16
00816467020167Control Kit - PSAPSA Controls250000032016-09-16

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