ASI RPR Dispensing Bottle NC-90900210

GUDID 00816057021246

Detection of Syphilis

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 ID00816057021246
NIH Device Record Key096a6d4f-6314-4f28-a737-4d1b4f9ea120
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RPR Dispensing Bottle
Version Model NumberNC-90900210
Catalog NumberNC-90900210
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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@arlintonscientific.com
Phone801-489-8911
Emailinfo@arlintonscientific.com
Phone801-489-8911
Emailinfo@arlintonscientific.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temp

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057021246 [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 Dispensing Bottle]

00816057021253Detection of Syphilis
00816057021246Detection of Syphilis

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