ASI RPR Carbon Antigen NC-987333

GUDID 00816057021024

Detection of Syphilis, 3 x 3ml

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00816057021024
NIH Device Record Key2f7efebf-006c-423a-a62e-397aad5175be
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RPR Carbon Antigen
Version Model NumberNC-987333
Catalog NumberNC-987333
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

Total Volume9 Milliliter
Total Volume9 Milliliter
Total Volume9 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057021024 [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 Carbon Antigen]

00816057021024Detection of Syphilis, 3 x 3ml
00816057020904Detection of Syphilis
00816057020898Detection of Syphilis

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