ASI RPR Card Test for Syphilis NC-987X10E

GUDID 00816057021093

Detection of Syphilis, 10 well, Export

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00816057021093
NIH Device Record Key81097146-b44c-4143-b62b-1fde98450e53
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RPR Card Test for Syphilis
Version Model NumberNC-987X10E
Catalog NumberNC-987X10E
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 Kittrue
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057021093 [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

On-Brand Devices [ASI RPR Card Test for Syphilis]

00816057021659Syphilis Screening Test, 500 Test, 15 well
00816057021123Detection of Syphilis, 30 Well, Cutsom
00816057021116Detection of Syphilis, 30 Well
00816057021109Detection of Syphilis, 15 well
00816057021093Detection of Syphilis, 10 well, Export
00816057021086Detection of Syphilis, 30 well, custom
00816057021079Detection of Syphilis, 30 well, Export
00816057021062Detection of Syphilis, 30 well
00816057021055Detection of Syphilis, 15 well
00816057021048Detection of Syphilis, no controls, 10 well, custom
00816057021031Detection of Syphilis, no controls, 10 well
00816057021017Detection of Syphilis, no controls, custom
00816057021000Detection of Syphilis, no controls
00816057020881Detection of Syphilis, 30 well
00816057020874Detection of Syphilis, 10 well
00816057020867Detection of Syphilis, 30 Well, TDH
00816057020850Detection of Syphilis, Export, 30 Well
00816057020843Detection of Syphilis, 30 well
00816057020836Detection of Syphilis, 10 well, TDH
00816057020812Detection of Syphilis, 10 well
00816057020805Detection of Syphilis, TDH
00816057020799Detection of Syphilis, Export
00816057020782Detection of Syphilis, Export, 3x3ml
00816057020775Detection for Syphilis, Export, No Controls
00816057020768Detection of Syphilis, Export (French)
00816057020751Syphilis screening test - Nontreponemal
00816057020744Detection of Syphilis, Export
00816057020720Detection of Syphilis, Export (French)
00816057020713Detection of Syphilis
00816057020706Syphilis Screening Test, Export
00816057020690Syphilis Screening Test
00816057021802Syphilis Screening Test with reactive and nonreactive controls. 500 test kit
00816057021796Syphilis Screening Test with reactive and nonreactive controls. 100 test kit
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.