DEVICE: CRP Control Set (00812137012159)

Device Identifier (DI) Information

CRP Control Set
L1 x 3 x 3mL, L2 x 3 x 3mL
In Commercial Distribution
502-155
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
00812137012159
GS1

6
048144997 *Terms of Use
These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
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?
41839 C-reactive protein (CRP) IVD, control
A material which is used to verify the performance of 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].
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DCK C-Reactive Protein, Antigen, Antiserum, And Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 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

fe4ff2c0-c8e2-4959-bf03-9403de7ec326
June 10, 2022
3
October 12, 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: 00812137012425 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8004533328
quality@cdsolinc.com
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