CHORUS ECHINOCOCCUS IgG 81284

GUDID 08033891320010

DIESSE DIAGNOSTICA SENESE SPA

Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08033891320010
NIH Device Record Key9790d6e8-7b2c-439a-9330-6f2e30a7d864
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHORUS ECHINOCOCCUS IgG
Version Model Number81284
Catalog Number81284
Company DUNS435036669
Company NameDIESSE DIAGNOSTICA SENESE SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033891320010 [Primary]

FDA Product Code

GPFAntigen, Agglutinating, Echinococcus Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

Devices Manufactured by DIESSE DIAGNOSTICA SENESE SPA

08033891320010 - CHORUS ECHINOCOCCUS IgG2024-01-30
08033891320010 - CHORUS ECHINOCOCCUS IgG2024-01-30
08033891320522 - VACU-TEC2024-01-30
08033891320645 - VACU-TEC CUVETTE-L2024-01-30
08033891320690 - VES-TEC CUVETTE-L2024-01-30
08033891321086 - VACU-TEC S.C.2024-01-30
08033891321093 - VACU-TEC S.C. STERILE2024-01-30
08033891322083 - CHORUS Q FEVER PHASE II IgG2024-01-30
08033891322434 - CHORUS MEASLES IgG2024-01-30

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