DEVICE: FRUC CONTROL 1 (05055273203127)
Device Identifier (DI) Information
FRUC CONTROL 1
FR2994
In Commercial Distribution
FR2994
RANDOX LABORATORIES LIMITED
FR2994
In Commercial Distribution
FR2994
RANDOX LABORATORIES LIMITED
This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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No |
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? |
---|---|---|---|---|
53276 | Fructosamine IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K023763 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Once reconstituted the components of the serum are stable for 28 days at +2oC to +8oC, and 1 month at –20oC when frozen once. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4fae1d23-4d5e-4372-b8db-a29ad5dc1de7
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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