FDA.reportPublic FDA data

VITROS

Primary DI
10758750033409
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6199924
Catalog number
6199924
Device description
VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Controls
Published
2021-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QKOReagent, coronavirus serological
QVPSARS-CoV-2 serology test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKOReagent, Coronavirus SerologicalUnknownN
QVPSars-Cov-2 Serology TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750033406PackageGS130In Commercial Distribution
10758750033409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003340620758750033406
1075875003340910758750033409

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 total antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not refreeze
Special Storage Condition, Specify00May be stored frozen, avoid repeated freeze-thaw cycles
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336179444Elecsys Anti-SARS-CoV 2Roche Diagnostics GmbHQVP2025-07-22
07613336179451Anti-SARS-CoV-2Roche Diagnostics GmbHQVP2025-07-22
07613336180167PreciControl Anti-SARS-CoV-2Roche Diagnostics GmbHQVP2025-07-22
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
10758750033607VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750033614VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750033621VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750033638VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750034550VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750035465VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
20758750033604VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750033611VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750033628VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750033635VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750034557VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
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