FDA.reportPublic FDA data

LIAISON® MUREX HCV Ab

Primary DI
08056771500197
Brand
LIAISON® MUREX HCV Ab
Company
DIASORIN S.P.A.
Model
318240
Published
2020-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056771500194PackageGS110In Commercial Distribution
08056771500197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805677150019418056771500194
08056771500197080567715001978056771500197

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus 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 the Hepatitis C 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
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
08056771500227LIAISON® MUREX Control HCV Ab3182412020-02-25
08056771500203LIAISON XL MUREX HIV Ab/Ag HT3182902021-05-04
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