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ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin

FDA UDI

Class II (US FDA UDI)

by Alba Bioscience Limited

Identity

Trade Name
ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin FDA UDI
Generic Name
Anti-A1 red blood cell grouping IVD, lectin FDA UDI
Device Name
For the in vitro detection and identification of human A1 red blood cellls FDA UDI
Model / Reference
Z241U FDA UDI
Description
For the in vitro detection and identification of human A1 red blood cellls FDA UDI

Identifiers

Primary DI / UDI-DI
05060242471063 FDA UDI
FDA Product Code
KSI FDA UDI
GMDN Term
Anti-A1 red blood cell grouping IVD, lectin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9550 FDA UDI
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

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: Anti-A1 red blood cell grouping IVD, lectin

ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin by Alba Bioscience Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-A1 red blood cell grouping IVD, lectin.

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 854261b4-5e1f-4af8-a6bb-afdc04ca0233 35 fields · synced Jun 1, 2026