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Beckman Coulter® PK® Systems Reagent Red Blood Cells (A1 & B)

FDA UDI

by Diagast

Identity

Trade Name
Beckman Coulter® PK® Systems Reagent Red Blood Cells (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 A1 and B cells formulated for the use in Beckman Coulter® PK® Systems FDA UDI
Model / Reference
17318 FDA UDI
Description
Reagent Red Blood Cells A1 and B cells formulated for the use in Beckman Coulter® PK® Systems FDA UDI

Identifiers

Catalog Number
17318 FDA UDI
Primary DI / UDI-DI
33661562173182 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

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

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

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

Beckman Coulter® PK® Systems Reagent Red Blood Cells (A1 & B) by Diagast — 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
Diagast

Sources (1)

  • FDA UDI a6a477f3-db53-4f12-b9a6-8ee9eda4cfa4 35 fields · synced May 30, 2026