FDA.reportPublic FDA data

LIAISON® anti-HAV

Primary DI
08056771100199
Brand
LIAISON® anti-HAV
Company
DIASORIN SPA
Model
310200
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOLHepatitis A Test (Antibody And Igm Antibody)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOLHepatitis A Test (Antibody And Igm Antibody)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082049000LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVDiaSorin, Inc.2008-12-05LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771100199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771100199080567711001998056771100199

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus 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 the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.

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
08056771103015LIAISON BRAHMS PCT II GEN3180902018-04-05
08056771104265LIAISON® XL MUREX Anti-HDV3182602026-01-12
08056771104272LIAISON® XL MUREX Control Anti-HDV3182612026-01-12
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
08056771104081LIAISON QUANTIferon TB Gold Plus3110402023-09-08
08056771200103LIAISON® ENDOCRINOLOGY DILUENT3191332018-09-24
08056771200332LIAISON® CONTROL THYROID 13892192016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590806446Access anti-HAV IgMBeckman Coulter, Inc.LOL2026-04-23
00380740197650AlinityAbbott GmbHLOL2023-11-04
00630414301259Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00630414301297Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00380740136628AlinityAbbott GmbHLOL2020-12-23
00380740131371AlinityAbbott GmbHLOL2020-11-06
00380740131562AlinityAbbott GmbHLOL2020-01-06
00380740131579AlinityAbbott GmbHLOL2020-01-06
00380740136611AlinityAbbott GmbHLOL2020-01-06
07613336129715Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
07613336129722Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
00630414597737Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597744Atellica IM aHAVM QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597775Atellica IM aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597768Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2017-12-22
04015630939855Elecsys Anti-HAV IgMRoche Diagnostics GmbHLOL2017-09-07
04015630939916Elecsys Anti-HAVRoche Diagnostics GmbHLOL2017-06-20
08056771100205LIAISON® Control anti-HAVDIASORIN SPALOL2016-09-24
00630414479996ADVIA Centaur® HAV IgMSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414480008ADVIA Centaur® HAV IgM QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481876ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481883ADVIA Centaur® Systems QC aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414498461ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414509259ADVIA Centaur® aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
04015630938841Elecsys AntiHAV AssayRoche Diagnostics GmbHLOL2016-09-20
04015630938858Elecsys AntiHAV IgMRoche Diagnostics GmbHLOL2016-09-20
00847865012362MONOLISABIO-RADLOL2016-09-12
00847865012379MONOLISABIO-RADLOL2016-09-12
00380740011079ARCHITECTAbbott GmbHLOL2016-09-09
00380740011086ARCHITECTAbbott GmbHLOL2016-09-09