DEVICE: SABS (05055273214444)
Device Identifier (DI) Information
SABS
SP8399
In Commercial Distribution
SP8399
RANDOX LABORATORIES LIMITED
SP8399
In Commercial Distribution
SP8399
RANDOX LABORATORIES LIMITED
This product is used for checking proper functioning of the sample fluid metering system as well as the photometric measuring system.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
58048 | Optical laboratory instrument performance standard calibrator/control IVD, single-use |
A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131554 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Special Storage Condition, Specify: R1 Stable on board the analyser for 30 days at approximately +10ºC. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
533fd618-6159-4a0a-87bb-16e6e0cbd5d8
December 20, 2022
7
September 26, 2016
December 20, 2022
7
September 26, 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
[?]
+44289445170
technical.services@randox.com
technical.services@randox.com