DEVICE: RABS (05055273205091)

Device Identifier (DI) Information

RABS
RP3857
In Commercial Distribution
RP3857
RANDOX LABORATORIES LIMITED
05055273205091
GS1

1
227530649 *Terms of Use
The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Optical instrument calibration/verification solution IVD A reference solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, microplate reader, real-time PCR instrument). Verification functions may include optical density (absorbance), fluorescent or luminescent accuracy and compensation, and linearity at specified wavelengths and/or stray light interference. It may also be used to verify pipetting/dispensing/aspiration/diluting functions of semi/automated liquid handling instruments using spectrophotometric measurement to determine concentration/residual volume. Solutions are typically single or short-term use.
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FDA Product Code

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Product Code Product Code Name
JJF Analyzer, Chemistry, Micro, For Clinical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K024014 000
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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: Stable on board the analyser for 30 days at approximately 10°C.
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

edb607db-40b7-409b-9c53-c663193d634e
July 06, 2018
3
September 26, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+44289445170
technical.services@randox.com
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