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Anti-K (KEL1)

FDA UDI

by Diagast

Identity

Trade Name
Anti-K (KEL1) FDA UDI
Generic Name
Anti-K (KEL001) red blood cell grouping IVD, antibody FDA UDI
Device Name
Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) (MS56) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual tube method. FDA UDI
Model / Reference
210533 FDA UDI
Description
Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) (MS56) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual tube method. FDA UDI

Identifiers

Catalog Number
210533 FDA UDI
Primary DI / UDI-DI
23661562105339 FDA UDI
GMDN Term
Anti-K (KEL001) red blood cell grouping IVD, antibody FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Anti-K (KEL001) red blood cell grouping IVD, antibody

Anti-K (KEL1) by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-K (KEL001) red blood cell grouping IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagast

Sources (1)

  • FDA UDI 3095137c-f8d2-46c7-a1fc-9294641c1c74 35 fields · synced May 30, 2026