ASI Disposible Stirrer Pipet NC-909001

GUDID 00816057021192

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 ID00816057021192
NIH Device Record Key152ff4a2-b360-4413-ab7d-f7a65956c830
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI Disposible Stirrer Pipet
Version Model NumberNC-909001
Catalog NumberNC-909001
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@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com

Device Dimensions

Total Volume0.05 Milliliter
Total Volume0.05 Milliliter
Total Volume0.05 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temp

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057021192 [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 Disposible Stirrer Pipet]

00816057021192Detection of Syphilis
00816057021185Disposable Pipet, 500/bag

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