DEVICE: Detector C-Reactacol (10722355001163)

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Device Identifier (DI) Information

Detector C-Reactacol
CRC-50

IMMUNOSTICS COMPANY, INC
10722355001163
GS1
50
A rapid color enhanced latex slide test for the detection of C-Reactive Protein
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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
C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a precipitation/immunodiffusion method. CRP is a marker associated with bacterial infection and inflammatory conditions.
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FDA Product Code

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Product Code Product Code Name
DCN SYSTEM, TEST, C-REACTIVE PROTEIN
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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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Do not freeze
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 20, 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: 80722355001162 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

[?]
+1(732)918-0770
technical@immunostics.com
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