DEVICE: ALS CAL (05055273200089)
Device Identifier (DI) Information
ALS CAL
AD5000
In Commercial Distribution
AD5000
RANDOX LABORATORIES LIMITED
AD5000
In Commercial Distribution
AD5000
RANDOX LABORATORIES LIMITED
The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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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? |
---|---|---|---|---|
45825 | Aldolase IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of aldolase in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIT | Calibrator, Secondary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142181 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: The calibration serum is stable for 5 days when reconstituted and stored at +2ºC to +8ºC. |
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
e8377660-1d37-44da-9aba-935764181af0
July 06, 2018
3
September 09, 2016
July 06, 2018
3
September 09, 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