DEVICE: ASI RPR Disposible Test Card (00816057021314)
Device Identifier (DI) Information
ASI RPR Disposible Test Card
NC-906010-25
In Commercial Distribution
NC-906010-25
ARLINGTON SCIENTIFIC, INC.
NC-906010-25
In Commercial Distribution
NC-906010-25
ARLINGTON SCIENTIFIC, INC.
Detection of Syphilis, 25 - 10 well
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
51819 | Treponema pallidum reagin antibody IVD, kit, agglutination |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GMP | Antisera, Control For Nontreponemal Tests |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K851504 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Room Temp |
Clinically Relevant Size
[?]Size Type Text |
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Area/Surface Area: 255.14 Square centimeter |
Device Record Status
61cb69f9-21b2-4937-87d6-2872599a74ef
July 06, 2018
3
July 08, 2016
July 06, 2018
3
July 08, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
801-489-8911
info@arlingtonscientific.com
info@arlingtonscientific.com