← Back to catalogue

Hemantigen (Pooled Cells)

FDA UDI

by Immucor, Inc.

Identity

Trade Name
Hemantigen (Pooled Cells) FDA UDI
Generic Name
Pooled antibody screening reagent red blood cell IVD, antigen FDA UDI
Device Name
Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors. FDA UDI
Model / Reference
0002223 FDA UDI
Description
Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors. FDA UDI

Identifiers

Catalog Number
0002223 FDA UDI
Primary DI / UDI-DI
10888234000174 FDA UDI
GMDN Term
Pooled antibody screening reagent red blood cell IVD, antigen FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

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: Pooled antibody screening reagent red blood cell IVD, antigen

Hemantigen (Pooled Cells) by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pooled antibody screening reagent red blood cell IVD, antigen.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI a2fbf456-e1ab-4400-b84d-e59eecd6447b 35 fields · synced May 30, 2026