DEVICE: CYSC CAL (05055273207439)

Device Identifier (DI) Information

CYSC CAL
CYS2699
In Commercial Distribution
CYS2699
RANDOX LABORATORIES LIMITED
05055273207439
GS1

1
227530649 *Terms of Use
The device is intended to be used for in the calibration of Cystatin C assays.
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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
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

[?]
Product Code Product Code Name
JIT Calibrator, Secondary
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K083906 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

896e8784-6f3d-44bf-a437-f9b0d88181ec
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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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