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ORTHOTM Sera Anti-Jka

FDA UDI

by Alba Bioscience Limited

Identity

Trade Name
ORTHOTM Sera Anti-Jka FDA UDI
Generic Name
Anti-Jk^a red blood cell grouping IVD, antibody FDA UDI
Device Name
The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test. FDA UDI
Model / Reference
6904548 FDA UDI
Description
The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test. FDA UDI

Identifiers

Primary DI / UDI-DI
10758750013029 FDA UDI
GMDN Term
Anti-Jk^a 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

No

FDA UDI

Prescription Use

Yes

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

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: Anti-Jk^a red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Jka by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-Jk^a red blood cell grouping IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alba Bioscience Limited

Sources (1)

  • FDA UDI c8945f43-3174-49c7-a7bf-d8d721994666 35 fields · synced Jun 1, 2026