ASI RPR Control Set NC-605002.5T

GUDID 00816057020942

Detection of Syphilis, TDH

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 ID00816057020942
NIH Device Record Key988a8d4d-b8b7-4bc9-9565-4d340bdf4705
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RPR Control Set
Version Model NumberNC-905002.5T
Catalog NumberNC-605002.5T
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 Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057020942 [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 Control Set]

00816057020973Detection of Syphilis
00816057020966Detection of Syphilis, Custom
00816057020959Detection of Syphilis
00816057020942Detection of Syphilis, TDH
00816057020935Detection of Syphilis, Custom
00816057020928Detection of Syphilis
00816057020911Detection of Syphilis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.