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WIESLAB anti-GBM semi quantitative kit

FDA UDI

Class II (US FDA UDI)

by Euro-Diagnostica AB

Identity

Trade Name
WIESLAB anti-GBM semi quantitative kit FDA UDI
Generic Name
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
GP104X FDA UDI

Identifiers

Catalog Number
GP104X FDA UDI
Primary DI / UDI-DI
07340058410721 FDA UDI
510(k) Number
K974169 FDA UDI
FDA Product Code
DBL FDA UDI
GMDN Term
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)

WIESLAB anti-GBM semi quantitative kit by Euro-Diagnostica AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Euro-Diagnostica AB

Sources (1)

  • FDA UDI e98876f7-2131-492d-9d02-bc3d332ef8e6 34 fields · synced May 30, 2026