DEVICE: CRP Calibrator Set (00812137012142)
Device Identifier (DI) Information
CRP Calibrator Set
5 x 2mL
In Commercial Distribution
502-154
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
5 x 2mL
In Commercial Distribution
502-154
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes |
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? |
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41838 | C-reactive protein (CRP) IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be 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 |
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DCK | C-Reactive Protein, Antigen, Antiserum, And Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
fd2eb551-ab08-495d-b884-404d0e6b9184
June 10, 2022
3
October 12, 2016
June 10, 2022
3
October 12, 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:
00812137012432
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004533328
quality@cdsolinc.com
quality@cdsolinc.com