← Back to catalogue

P KDY Pack 4 WELL

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
P KDY Pack 4 WELL FDA UDI
Generic Name
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
5601 FDA UDI

Identifiers

Catalog Number
5601 FDA UDI
Primary DI / UDI-DI
00813545020583 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

No

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

P KDY Pack 4 WELL 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI b70bea9e-94a4-460d-8af7-c55497d4649e 34 fields · synced May 30, 2026