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GBM P KDY Test(L) 48

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
GBM P KDY Test(L) 48 FDA UDI
Generic Name
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
5648L FDA UDI

Identifiers

Catalog Number
5648L FDA UDI
Primary DI / UDI-DI
00813545022938 FDA UDI
FDA Product Code
MVJ FDA UDI
GMDN Term
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay 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

Yes

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

Yes

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, fluorescent immunoassay

GBM P KDY Test(L) 48 by Scimedx Corp. — 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, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI a5e0b9bd-b37b-4394-96cf-b46d3d3a593e 34 fields · synced Jun 6, 2026