FDA.reportPublic FDA data

LIAISON® SARS-CoV-2 S1/S2 IgG

Primary DI
08056771103664
Brand
LIAISON® SARS-CoV-2 S1/S2 IgG
Company
DIASORIN SPA
Model
311460
Published
2020-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
08056771103664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771103664080567711036648056771103664

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

Contacts#

Phone, Email table
PhoneEmail
651-439-9710info@diasorin.com

Regulatory Flags#

DUNS number
630822989
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771100625LIAISON® VZV IgG3104952016-09-24
08056771100632LIAISON® Control VZV IgG3104962016-09-24
08056771103015LIAISON BRAHMS PCT II GEN3180902018-04-05
08056771104265LIAISON® XL MUREX Anti-HDV3182602026-01-12
08056771104272LIAISON® XL MUREX Control Anti-HDV3182612026-01-12
08056771100199LIAISON® anti-HAV3102002016-09-24
08056771100205LIAISON® Control anti-HAV3102012016-09-24
08056771100571LIAISON® Rubella IgG3104602016-09-24
08056771100588LIAISON® Rubella IgG TRI-Controls3104612016-09-24
08056771100618LIAISON® Treponema Assay3104802016-09-24
08056771102148LIAISON® XLI00502016-09-24
08056771101943LIAISON® CMV IgM3107502016-09-24
08056771102872LIAISON MDXMOL10012017-04-04
08056771102889LIAISON MDXMOL10112017-04-04
08056771103268LIAISON Quantiferon TB Gold Plus3110202019-12-09
08056771104029LIAISON® Biotrin Parvovirus B19 IgG Plus3115502024-04-08
08056771104036LIAISON® Biotrin Control Parvovirus B19 IgG Plus3115512024-04-08
08056771104166LIAISON® VZV IgG HT 3118702024-03-15
08056771104173LIAISON® Control VZV IgG HT 3118712024-03-15
08056771104098LIAISON QUANTIferon TB Gold Plus3110402023-12-14

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