ELDON SCHOOL KIT SKA 2511-30 - For self-testing of ABO and RhD Blood groups. Not - Eldon Biologicals A/S

Duns Number:307910120

Device Description: For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to For self-testing of ABO and RhD Blood groups. Not for use for screening purposes prior to transfusion. Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.

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More Product Details

Catalog Number

504-32

Brand Name

ELDON SCHOOL KIT SKA 2511-30

Version/Model Number

504-32v03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K790282,K790282

Product Code Details

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Device Record Status

Public Device Record Key

695c0654-073e-42ad-8f37-c824ebce87a2

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELDON BIOLOGICALS A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23