DEVICE: DOCTOR´S KIT DKS RhD-25 (05713494000085)
Device Identifier (DI) Information
DOCTOR´S KIT DKS RhD-25
660-01v05
In Commercial Distribution
660-01
Eldon Biologicals A/S
660-01v05
In Commercial Distribution
660-01
Eldon Biologicals A/S
For 75 RhD blood group determinations. Dry format cards for ABO and/or 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 |
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Storage Environment Temperature: between 5 and 37 Degrees Celsius |
Handling Environment Temperature: between 5 and 37 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9bf073e0-94cf-4cd6-a38c-7c5a19240c40
July 06, 2018
3
September 07, 2016
July 06, 2018
3
September 07, 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