DEVICE: TDM CAL (05055273206470)

Device Identifier (DI) Information

TDM CAL
TD3417
In Commercial Distribution
TD3417
RANDOX LABORATORIES LIMITED
05055273206470
GS1

1
227530649 *Terms of Use
This product is intended for use in the calibration of therapeutic drug assays.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DKB Calibrators, Drug Mixture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c8a258f7-cd97-4127-958a-a3d55bcbfd93
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+442894451070
technical.services@randox.com
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