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DG Gel 8 A/B/D

FDA UDI

by Diagnostic Grifols Sa

Identity

Trade Name
DG Gel 8 A/B/D FDA UDI
Generic Name
ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination FDA UDI
Device Name
The DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Model / Reference
210384 FDA UDI
Description
The DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
210384 FDA UDI
Primary DI / UDI-DI
08437014205930 FDA UDI
GMDN Term
ABO/Rh(D)/Kell multiple blood grouping 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

No

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: ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination

DG Gel 8 A/B/D by Diagnostic Grifols Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Grifols Sa

Sources (1)

  • FDA UDI c3cc8179-6a8e-4a96-bf99-a4c1d2557248 35 fields · synced May 30, 2026