LIAISON XL MUREX HBcIgM

GUDID 08056771103381

DIASORIN SPA

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID08056771103381
NIH Device Record Keye1d279e6-3dcf-4b35-a47f-b563b36d37b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIAISON XL MUREX HBcIgM
Version Model Number318140
Company DUNS630822989
Company NameDIASORIN SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056771103381 [Primary]
GS118056771103388 [Package]
Package: [10 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-21
Device Publish Date2021-04-13

Devices Manufactured by DIASORIN SPA

08056771104029 - LIAISON® Biotrin Parvovirus B19 IgG Plus2024-04-16 Italy manufactured kit.
08056771104036 - LIAISON® Biotrin Control Parvovirus B19 IgG Plus2024-04-16 Italy manufactured kit.
08056771104166 - LIAISON® VZV IgG HT 2024-03-25
08056771104173 - LIAISON® Control VZV IgG HT 2024-03-25
08056771104098 - LIAISON QUANTIferon TB Gold Plus2023-12-22 Italy manufactured kit.
08056771104081 - LIAISON QUANTIferon TB Gold Plus2023-09-18 Italy manufactured kit.
08056771603300 - LIAISON QUANTIferon TB Gold Plus2023-07-31
08056771200103 - LIAISON® ENDOCRINOLOGY DILUENT2023-06-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.