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Anti-D (Monoclonal Blend) Gamma-clone

FDA UDI

by Immucor, Inc.

Identity

Trade Name
Anti-D (Monoclonal Blend) Gamma-clone FDA UDI
Generic Name
Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
Device Name
This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent. FDA UDI
Model / Reference
0420503 FDA UDI
Description
This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent. FDA UDI

Identifiers

Catalog Number
0420503 FDA UDI
Primary DI / UDI-DI
10888234001768 FDA UDI
GMDN Term
Anti-Rh(D) 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

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: Anti-Rh(D) red blood cell grouping IVD, antibody

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

Similar devices

Also classified as Anti-Rh(D) 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 0135a4fe-9498-4582-9531-c8a08a68f226 36 fields · synced Jun 8, 2026