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Reverse-Cyte 0.8% (A1 +2 more)

FDA UDI

by Medion Grifols Diagnostics AG

Identity

Trade Name
Reverse-Cyte 0.8% (A1, A2, 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 for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnostic use. FDA UDI
Model / Reference
3x10 ml FDA UDI
Description
Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
213662 FDA UDI
Primary DI / UDI-DI
07640137340322 FDA UDI
GMDN Term
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination FDA UDI
Models / Variants
A1 FDA UDI
A2 FDA UDI
B FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Reverse-Cyte 0.8% (A1 +2 more) by Medion Grifols Diagnostics AG — FDA UDI — listed in FDA GUDID — 3 models — 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

Sources (1)

  • FDA UDI 278164c3-6f09-481b-bc26-44c107b8c6fc 33 fields · synced Jun 8, 2026