ASI Syphilis Reference Panel NC-907000

GUDID 00816057020980

Detection of Syphilis, 10 samples

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00816057020980
NIH Device Record Key88a4a3c6-226f-4468-9b72-1e9c463fd3ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI Syphilis Reference Panel
Version Model NumberNC-907000
Catalog NumberNC-907000
Company DUNS785966607
Company NameARLINGTON SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com

Device Dimensions

Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057020980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMPAntisera, Control For Nontreponemal Tests

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-08

Devices Manufactured by ARLINGTON SCIENTIFIC, INC.

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00816057021697 - ASI RPR Automated Control Set 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls.
00816057021703 - ASI RPR Automated Control Set 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive and nonreactive controls
00816057021710 - ASI Evolution RPR Titration Diluent2023-12-27 RPR Sample Diluent used on the ASI Evolution Analyzer for performing sample titrations. 25 ml
00816057021796 - ASI RPR Card Test for Syphilis2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 100 test kit
00816057021802 - ASI RPR Card Test for Syphilis2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 500 test kit

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