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ALBAcyte Antibody Screen (2-Cell)

FDA UDI

by Alba Bioscience Limited

Identity

Trade Name
ALBAcyte Antibody Screen (2-Cell) FDA UDI
Generic Name
Antibody screening reagent red blood cell IVD, kit, agglutination FDA UDI
Device Name
Reagent Red Blood Cells, ALBAcyte Antibody Screen (2-Cell) for tube techniques, 2-3% suspension. FDA UDI
Model / Reference
Z454U FDA UDI
Description
Reagent Red Blood Cells, ALBAcyte Antibody Screen (2-Cell) for tube techniques, 2-3% suspension. FDA UDI

Identifiers

Primary DI / UDI-DI
05060242471360 FDA UDI
GMDN Term
Antibody screening reagent red blood cell IVD, kit, agglutination 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

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: Antibody screening reagent red blood cell IVD, kit, agglutination

ALBAcyte Antibody Screen (2-Cell) by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antibody screening reagent red blood cell IVD, kit, agglutination.

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 9fef8c2d-6269-47e4-bbd3-703490113591 34 fields · synced May 30, 2026