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ALBAclone® Anti-Human Globulin Anti-C3d

FDA UDI

by Alba Bioscience Limited

Identity

Trade Name
ALBAclone® Anti-Human Globulin Anti-C3d FDA UDI
Generic Name
Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody FDA UDI
Device Name
Anti-Human Globulin, Anti-C3d, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3b and/or C3d components. FDA UDI
Model / Reference
Z360U FDA UDI
Description
Anti-Human Globulin, Anti-C3d, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3b and/or C3d components. FDA UDI

Identifiers

Primary DI / UDI-DI
05060242471414 FDA UDI
GMDN Term
Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) 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

Yes

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: Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody

ALBAclone® Anti-Human Globulin Anti-C3d by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) 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 8dbe3e55-86a4-4ba8-a6d3-aae3862ddadb 34 fields · synced Jun 1, 2026