DEVICE: CK NAC (05055273201482)
Device Identifier (DI) Information
CK NAC
CK3812
In Commercial Distribution
CK3812
RANDOX LABORATORIES LIMITED
CK3812
In Commercial Distribution
CK3812
RANDOX LABORATORIES LIMITED
The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
52989 | Creatine kinase (CK) multiple isoenzyme IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K923511 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Stable for 3 weeks in the instrument at approximately +10°C or 3 days at +15 to +25°C once reconstituted. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cbaae54f-298f-452d-b844-d22071da1474
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+442894451070
technical.services@randox.com
technical.services@randox.com