DEVICE: CRP (05055273201819)
Device Identifier (DI) Information
CRP
CP7949
Not in Commercial Distribution
CP7949
RANDOX LABORATORIES LIMITED
CP7949
Not in Commercial Distribution
CP7949
RANDOX LABORATORIES LIMITED
The device is intended for the quantitative in vitro diagnostic determination of C-Reactive Protein (CRP) concentration in serum.
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? |
---|---|---|---|---|
53707 | C-reactive protein (CRP) IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DCK | C-Reactive Protein, Antigen, Antiserum, And Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K953212 | 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
30868063-5b1d-4086-b28b-7a15d43d56a2
June 10, 2022
4
September 09, 2016
June 10, 2022
4
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 |
---|---|---|---|---|---|
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