DG Gel 8 ABO/Rh+Kell - The DG Gel 8 ABO/Rh + Kell card is for the - DIAGNOSTIC GRIFOLS SA

Duns Number:463625602

Device Description: The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of human blood samples.For use with the DG Gel System.For in vitro diagnostic use.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

210383

Brand Name

DG Gel 8 ABO/Rh+Kell

Version/Model Number

210383

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

8b8ca24c-c7ea-49e0-bab3-27e20540bbd6

Public Version Date

January 31, 2022

Public Version Number

3

DI Record Publish Date

March 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAGNOSTIC GRIFOLS SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 9