DEVICE: TDM CAL (05055273206470)
Device Identifier (DI) Information
TDM CAL
TD3417
In Commercial Distribution
TD3417
RANDOX LABORATORIES LIMITED
TD3417
In Commercial Distribution
TD3417
RANDOX LABORATORIES LIMITED
This product is intended for use in the calibration of therapeutic drug assays.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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? |
---|---|---|---|---|
55234 | Multiple-therapy therapeutic drug monitoring IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DKB | Calibrators, Drug Mixture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K012318 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Once reconstituted, the components of the Therapeutic Drug Calibrators are stable for 28 days at +2ºC to +8ºC in. Freshly reconstituted calibrators may also be stored ≤–20ºC for up to 8 weeks. |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c8a258f7-cd97-4127-958a-a3d55bcbfd93
December 21, 2020
3
September 24, 2016
December 21, 2020
3
September 24, 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 |
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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