DEVICE: EtOH CAL/CONTROL (05055273207873)

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Device Identifier (DI) Information

EtOH CAL/CONTROL
DA2703
DA2703
RANDOX LABORATORIES LIMITED
05055273207873
GS1
1
The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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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
Ethanol (ETOH) IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
Ethanol (ETOH) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
DLJ Calibrators, Drug Specific
LAS Drug Specific Control Materials
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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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: The Ethanol Calibrators and Controls are stable for 28 days at +2°C to +8°C.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
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

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+442894451070
technical.services@randox.com
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