ASI RPR Card Test for Syphilis NC-900500E

GUDID 00816057020799

Detection of Syphilis, Export

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00816057020799
NIH Device Record Keyce24e093-6a25-4bcf-a7d5-91fa3a458ecd
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RPR Card Test for Syphilis
Version Model NumberNC-900500E
Catalog NumberNC-900500E
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
GS100816057020799 [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]

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00816057020799Detection of Syphilis, Export
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00816057020775Detection for Syphilis, Export, No Controls
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00816057020751Syphilis screening test - Nontreponemal
00816057020744Detection of Syphilis, Export
00816057020720Detection of Syphilis, Export (French)
00816057020713Detection of Syphilis
00816057020706Syphilis Screening Test, Export
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00816057021802Syphilis Screening Test with reactive and nonreactive controls. 500 test kit
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