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Erytypecell® A1 & B

FDA UDI

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
Erytypecell® 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; 1.0 - 1.3%;pooled cells for reverse grouping with the TANGO instruments; 2x10ml FDA UDI
Model / Reference
816056100 FDA UDI
Description
Reagent Red Blood Cells; 1.0 - 1.3%;pooled cells for reverse grouping with the TANGO instruments; 2x10ml FDA UDI

Identifiers

Catalog Number
816056100 FDA UDI
Primary DI / UDI-DI
07611969952656 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

Erytypecell® 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

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Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI bbe7788e-c2a8-4a09-8a04-a9ea97fb68f7 35 fields · synced Jun 6, 2026