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ALBAcyte IgG Sensitized Red Blood Cells II

FDA UDI

Class II (US FDA UDI)

by Alba Bioscience Limited

Identity

Trade Name
ALBAcyte IgG Sensitized Red Blood Cells II FDA UDI
Generic Name
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI
Device Name
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT). FDA UDI
Model / Reference
Z443U FDA UDI
Description
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT). FDA UDI

Identifiers

Primary DI / UDI-DI
05060242472329 FDA UDI
FDA Product Code
KSF FDA UDI
GMDN Term
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9650 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

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: Immunoglobulin-sensitized reagent red blood cell IVD, control

ALBAcyte IgG Sensitized Red Blood Cells II by Alba Bioscience Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunoglobulin-sensitized reagent red blood cell IVD, control.

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 7ccf28d2-3526-4fbb-a105-fde112498342 35 fields · synced Jun 6, 2026