FDA.reportPublic FDA data

LIAISON XL MUREX HIV Ab/Ag HT

Primary DI
08056771500203
Brand
LIAISON XL MUREX HIV Ab/Ag HT
Company
DIASORIN S.P.A.
Model
318290
Published
2021-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056771500200PackageGS110In Commercial Distribution
08056771500203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805677150020018056771500200
08056771500203080567715002038056771500203

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an chemiluminescent immunoassay method.

Regulatory Flags#

DUNS number
216357118
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
08056771500197LIAISON® MUREX HCV Ab3182402020-02-25
08056771500227LIAISON® MUREX Control HCV Ab3182412020-02-25
08056771500234LIAISON XL MUREX Control HIV Ab/Ag HT3182912021-05-04
18056771500200LIAISON XL MUREX HIV Ab/Ag HT3182902021-05-04
18056771500231LIAISON XL MUREX Control HIV Ab/Ag HT3182912021-05-04
08056771103589LIAISON XL MUREX HBsAg Confirmatory 3181102021-04-13
08056771500180LIAISON XL MUREX HBsAg Qual3182502021-04-13
08056771500210LIAISON XL MUREX Control HBsAg Qual3182512021-04-13
28056771103583LIAISON XL MUREX HBsAg Confirmatory 3181102021-04-13
18056771500187LIAISON XL MUREX HBsAg Qual3182502021-04-13
28056771500214LIAISON XL MUREX Control HBsAg Qual3182512021-04-13