Anti-B (Murine Monoclonal) Gamma-clone

FDA UDI

by Immucor, Inc.

Identity

Trade Name: Anti-B (Murine Monoclonal) Gamma-clone FDA UDI
Generic Name: Anti-B red blood cell grouping IVD, antibody FDA UDI
Device Name: This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent. FDA UDI
Model / Reference: 0413210 FDA UDI
Description: This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent. FDA UDI

Identifiers

Catalog Number: 0413210 FDA UDI
Primary DI / UDI-DI: 10888234001720 FDA UDI
GMDN Term: Anti-B red blood cell grouping IVD, antibody FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Anti-B red blood cell grouping IVD, antibody

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

Similar devices

Also classified as Anti-B red blood cell grouping IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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

Manufacturer

Manufacturer: Immucor, Inc.

Sources (1)

FDA UDI 754a8073-1646-46ef-b115-72c72ff061ac 36 fields · synced Jun 6, 2026