FDA.reportPublic FDA data

Anti-SARS-CoV-2

Primary DI
07613336179451
Brand
Anti-SARS-CoV-2
Company
Roche Diagnostics GmbH
Model
09203095190
Catalog number
09203095190
Published
2025-07-22
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
QVPSARS-CoV-2 serology test

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250768000
K253839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250768000Elecsys Anti-SARS-CoV-2Roche Diagnostics2025-06-10QVP
K253839000Elecsys Anti-SARS-CoV-2Roche Diagnostics2025-12-17QVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336179451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336179451076133361794517613336179451

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336179444Elecsys Anti-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
20758750033635VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
20758750034557VITROSORTHO CLINICAL DIAGNOSTICSQVP2023-11-22
10758750033409VITROSORTHO CLINICAL DIAGNOSTICSQVP2021-03-22