DEVICE: Cyclosporine Calibrators (04015630915637)
Device Identifier (DI) Information
Cyclosporine Calibrators
20766305122
In Commercial Distribution
20766305122
Roche Diagnostics GmbH
20766305122
In Commercial Distribution
20766305122
Roche Diagnostics GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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55439 | Cyclosporin A/cyclosporine 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 the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DLJ | CALIBRATORS, DRUG SPECIFIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P920031 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and -10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0abff2a2-cfee-4507-8b9f-a2ec290bf1a4
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 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
[?]
No Customer Contact currently defined