DEVICE: CAL 2 (05055273200959)
Device Identifier (DI) Information
CAL 2
CAL2350
In Commercial Distribution
CAL2350
RANDOX LABORATORIES LIMITED
CAL2350
In Commercial Distribution
CAL2350
RANDOX LABORATORIES LIMITED
The device is intended for use as a calibrator in clinical chemistry assays. Randox calibration sera are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47868 | Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JIX | Calibrator, Multi-Analyte Mixture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K053153 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
430d17df-e4df-4714-a725-475f1e3b0131
December 21, 2020
4
September 16, 2016
December 21, 2020
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+442894451070
technical.services@randox.com
technical.services@randox.com