Duns Number:307910120
Device Description: For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for s For ABO and Rh D blood grouping Para ABO y Rh D agrupación de la sangre. Not for use for screening purposes prior totransfusion. No para el uso para defender propósitos antes de la transfusión. Dry format cards for ABO and/or RhD determinationfor the grouping of stabilized venous blood, capillary blood or washed red cells.
Catalog Number
414-03
Brand Name
ELDONBOX 2521-100 100 ELDONCARD 2521
Version/Model Number
414-03v03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
b602f80f-052d-47fc-8236-7538b51089d8
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
February 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |