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 to transfusion.No para el uso para defender propósitos antes de la transfusión.Dry format cards for ABO and/or RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Catalog Number
404-02
Brand Name
ELDONBOX 2511-100 100 ELDONCARD 2511
Version/Model Number
404-02v06
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
e26d8bf0-c3f9-4e2d-abac-8a9f2f1d8168
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
November 04, 2020
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 |