DEVICE: Gentian Cystatin C Calibrator Kit (07090038460108)

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Device Identifier (DI) Information

Gentian Cystatin C Calibrator Kit
1051

Gentian AS
07090038460108
GS1
1
The Gentian Cystatin C Calibrator kit is intended to be used to establish a calibration curve for measuring Cystatin C concentration in human serum or plasma with the Gentian Cystatin C Immunoassay.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Cystatin C IVD, calibrator A material which is used to establish known points of reference for an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
NDY Test, Cystatin C
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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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
November 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
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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