FDA.reportPublic FDA data

VITROS

Primary DI
10758750034567
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6199975
Catalog number
6199975
Device description
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack
Published
2021-11-08
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
false

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
10758750034567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875003456710758750034567

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials 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) 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
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
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
10758750035656VITROS627222262722222025-05-21
10758750005345ORTHO9337309337302025-02-17
10758750005031VITROS856804085680402016-08-10
10758750005352ORTHO934090F934090F2016-08-24
10758750030149ORTHO690463069046302016-08-24
10758750000067VITROS179235717923572020-06-06
10758750000388VITROS198821119882112016-08-23
10758750000593VITROS680012068001202016-08-10
10758750000616VITROS680018968001892016-08-23
10758750001354VITROS680176768017672016-08-26
10758750001743VITROS680198868019882016-08-10
10758750001750VITROS680198968019892016-08-23
10758750001774VITROS680199168019912016-08-23
10758750001811VITROS680199568019952016-08-23
10758750001828VITROS680199668019962016-08-26
10758750001835VITROS680199768019972016-08-26
10758750001842VITROS680199868019982016-08-26
10758750002283VITROS680221468022142016-08-26
10758750002290VITROS680221668022162016-08-23
10758750002535VITROS680230468023042016-08-23

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
20758750035462VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
03610522220519PlateliaBIO-RADQKO2023-07-03
03610522220526PlateliaBIO-RADQKO2023-07-03
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
10758750034581VITROSORTHO-CLINICAL DIAGNOSTICS, INC.QKO2021-11-08
04049016150244Anti-SARS-CoV-2 S1 Curve ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGQKO2021-10-25
00630414297590Dimension CV2T AssaySiemens Healthcare Diagnostics Inc.QKO2021-08-09
00630414297620DV/DM COV2T/CV2T POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QKO2021-08-09