FDA.reportPublic FDA data

VITROS

Primary DI
20758750033635
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6199954
Catalog number
6199954
Device description
VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Calibrator
Published
2023-11-22
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
QVPSARS-CoV-2 serology test

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210040000VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total CalibratorsOrtho-Clinical Diagnostics, Inc.2023-05-05QVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750033635PackageGS130In Commercial Distribution
10758750033638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003363520758750033635
1075875003363810758750033638

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 total antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies 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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
DM exempt
false
Premarket exempt
false
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
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
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
20758750033604VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750033611VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750033628VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750034557VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750033409VITROSORTHO CLINICAL DIAGNOSTICSQVP2021-03-22