DEVICE: ASI CRP Slide Test (00081605020362)

Device Identifier (DI) Information

ASI CRP Slide Test
NC-500050E
In Commercial Distribution
NC-500050E
ARLINGTON SCIENTIFIC, INC.
00081605020362
GS1

1
785966607 *Terms of Use
Detection of C-Reactive Protein, Export
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Device Characteristics

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

GMDN

[?]

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

[?]
Product Code Product Code Name
DCN System, Test, C-Reactive Protein
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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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50 Test
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Device Record Status

80af7fc5-1a25-47fe-9d7f-b2bc49107d4b
March 29, 2018
2
July 08, 2016
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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
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
801-489-8911
info@arlingtonscientific.com
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