DEVICE: ARK™ Pregabalin Urine Calibrator (00858724003292)
Device Identifier (DI) Information
ARK™ Pregabalin Urine Calibrator
5035-0002-00
In Commercial Distribution
5035-0002-00
ARK DIAGNOSTICS INC
5035-0002-00
In Commercial Distribution
5035-0002-00
ARK DIAGNOSTICS INC
ARK™ Pregabalin Urine Calibrator is intended for use in calibration of the ARK™ Pregabalin Urine Assay.
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? |
---|---|---|---|---|
61980 | Multiple anticonvulsant 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 anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DLJ | Calibrators, Drug Specific |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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
ce484425-c136-4f64-8e02-926184bf3ba2
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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
[?]
5102706270
customersupport@ark-tdm.com
customersupport@ark-tdm.com