FDA.reportPublic FDA data

LIAISON® XL MUREX Anti-HDV

Primary DI
08056771104265
Brand
LIAISON® XL MUREX Anti-HDV
Company
DIASORIN SPA
Model
318260
Device description
LIAISON® XL MUREX Anti-HDV assay - Italy manufactured kit
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
SGWDevice To Detect Antibodies To Hepatitis D Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGWDevice To Detect Antibodies To Hepatitis D VirusImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250032000LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)DiaSorin, Inc.2025-12-23SGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771104265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771104265080567711042658056771104265

GMDN Terms#

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

Regulatory Flags#

DUNS number
630822989
Device count
1
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
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
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
08056771104272LIAISON® XL MUREX Control Anti-HDVDIASORIN SPASGW2026-01-12