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IH-Cell I-II-III

FDA UDI

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
IH-Cell I-II-III FDA UDI
Generic Name
Antibody screening reagent red blood cell IVD, kit, agglutination FDA UDI
Device Name
Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in detection of unexpected antibodies with IH-Cards; 3 x 10 mL FDA UDI
Model / Reference
814030100 FDA UDI
Description
Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in detection of unexpected antibodies with IH-Cards; 3 x 10 mL FDA UDI

Identifiers

Catalog Number
814030100 FDA UDI
Primary DI / UDI-DI
07611969952267 FDA UDI
GMDN Term
Antibody screening reagent red blood cell IVD, kit, agglutination 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

Yes

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: Antibody screening reagent red blood cell IVD, kit, agglutination

IH-Cell I-II-III by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antibody screening reagent red blood cell IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI bb72b91f-ef6c-44f1-9aec-2453b179485e 35 fields · synced May 30, 2026