← Back to catalogue

Biotestcell® A1 & B

FDA UDI

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
Biotestcell® A1 & B FDA UDI
Generic Name
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination FDA UDI
Device Name
Reagent Red Blood Cells; Biotestcell® A1 & B; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 2x10ml FDA UDI
Model / Reference
816057100 FDA UDI
Description
Reagent Red Blood Cells; Biotestcell® A1 & B; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 2x10ml FDA UDI

Identifiers

Catalog Number
816057100 FDA UDI
Primary DI / UDI-DI
07611969952663 FDA UDI
GMDN Term
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) 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: Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Biotestcell® A1 & B by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination.

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
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI adb0e6be-7574-4d7f-af06-55d80f059595 35 fields · synced Jun 8, 2026