DEVICE: D LDL/HDL CAL (05055273201239)

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Device Identifier (DI) Information

D LDL/HDL CAL
CH2673
CH2673
RANDOX LABORATORIES LIMITED
05055273201239
GS1
1
The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods
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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
High-density lipoprotein (HDL) cholesterol 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 high-density lipoprotein (HDL) cholesterol lipid in a clinical specimen.
Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIS Calibrator, Primary
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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: Once reconstituted, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.
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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 16, 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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