WIESLAB antiGBM, ANCA Screen kit GCP100

GUDID 07340058410707

Euro-Diagnostica AB

Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07340058410707
NIH Device Record Keya4f5ac4e-00a5-44c6-a244-c325364a2647
Commercial Distribution StatusIn Commercial Distribution
Brand NameWIESLAB antiGBM, ANCA Screen kit
Version Model NumberGCP100
Catalog NumberGCP100
Company DUNS559894501
Company NameEuro-Diagnostica AB
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107340058410707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

Devices Manufactured by Euro-Diagnostica AB

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07340058410035 - DIASTAT anti-dsDNA2018-07-06
07340058410059 - DIASTST anti-Sm2018-07-06
07340058410110 - DIASTAT anti-thyroglobulin2018-07-06
07340058410134 - DIASTAT anti-Thyroid Peroxidase2018-07-06
07340058410417 - DIASTAT anti-Mitochondrial2018-07-06
07340058410431 - CCPoint2018-07-06

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