DEVICE: BENZ CAL (05055273207972)

Device Identifier (DI) Information

BENZ CAL
DA3129
In Commercial Distribution
DA3129
RANDOX LABORATORIES LIMITED
05055273207972
GS1

1
227530649 *Terms of Use
The Randox Benzodiazepines Calibrator Set is intended for use in the calibration of the Benzodiazepines assay. The Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Benzodiazepine group IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
DLJ Calibrators, Drug Specific
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132090 000
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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: The Benzodiazepines Calibrator materials are stable for 28 days at +2°C to +8°C once opened
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

24c11ae2-49df-4a94-9789-9c3c5754c012
July 06, 2018
3
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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