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Anti-e (Monoclonal Blend) Gamma-clone

FDA UDI

by Immucor, Inc.

Identity

Trade Name
Anti-e (Monoclonal Blend) Gamma-clone FDA UDI
Generic Name
Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
Device Name
This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial. FDA UDI
Model / Reference
0066424 FDA UDI
Description
This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial. FDA UDI

Identifiers

Catalog Number
0066424 FDA UDI
Primary DI / UDI-DI
10888234001379 FDA UDI
GMDN Term
Anti-E [RH005] red blood cell grouping IVD, antibody 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: Anti-E [RH005] red blood cell grouping IVD, antibody

Anti-e (Monoclonal Blend) Gamma-clone by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-E [RH005] red blood cell grouping IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor, Inc.

Sources (1)

  • FDA UDI 8925db07-47f6-4fa4-b5fc-9cddbe4154dd 35 fields · synced May 30, 2026