DEVICE: DOCTOR'S KIT DKS RhD-25 (05713494000351)
Device Identifier (DI) Information
DOCTOR'S KIT DKS RhD-25
669-00v07
In Commercial Distribution
669-00
Eldon Biologicals A/S
669-00v07
In Commercial Distribution
669-00
Eldon Biologicals A/S
For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
52647 | Anti-Rh(D) red blood cell grouping IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, using an agglutination method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSZ | System, Test, Automated Blood Grouping And Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K790282 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 5 and 37 Degrees Celsius |
Storage Environment Temperature: between 5 and 37 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
62a6323b-d9c0-4dc4-8585-baee4dae103d
December 20, 2022
5
December 13, 2016
December 20, 2022
5
December 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05713494000320
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4545931111
eldoncard@eldoncard.com
eldoncard@eldoncard.com