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ORTHOTM Sera Anti-Leb Blood Grouping Reagent

FDA UDIEUDAMED

by Alba Bioscience Limited

Identity

Trade Name
ORTHOTM Sera Anti-Leb Blood Grouping Reagent FDA UDI
Generic Name
Anti-Le^b red blood cell grouping IVD, antibody FDA UDI
Device Name
The Anti-Leb reagent (Anti-LE2) is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test. FDA UDI
Model / Reference
6904558 FDA UDI
Description
The Anti-Leb reagent (Anti-LE2) is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test. FDA UDI

Identifiers

Primary DI / UDI-DI
10758750013111 FDA UDI
GMDN Term
Anti-Le^b 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

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-Le^b red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Leb Blood Grouping Reagent by Alba Bioscience Limited — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Anti-Le^b red blood cell grouping IVD, antibody.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alba Bioscience Limited

Sources (2)

  • FDA UDI a6ac4828-9b8f-4916-af9e-d2f1e932f829 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026