DEVICE: CK-MB CAL (05055273201451)

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Device Identifier (DI) Information

CK-MB CAL
CK2393
CK2393
RANDOX LABORATORIES LIMITED
05055273201451
GS1
1
The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.
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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
Creatine kinase myocardial isoenzyme (CKMB) 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 creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIT Calibrator, Secondary
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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: Once reconstituted CK-MB is stable in the serum for 5 days at +4°C, 8 hours at +25°C and 4 weeks at –20°C when frozen once.
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 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)

[?]
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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