ASI RF Direct Slide Test NC-700100DC

GUDID 00816057020485

Detection of Rheumatoid Factor

ARLINGTON SCIENTIFIC, INC.

Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816057020485
NIH Device Record Key88a23d61-1d73-4ca5-9681-61414f0905f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RF Direct Slide Test
Version Model NumberNC-700100DC
Catalog NumberNC-700100DC
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
GS100816057020485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHRSystem, Test, Rheumatoid Factor

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 RF Direct Slide Test]

00816057020508Detection of Rheumatoid Factor
00816057020492Detection fo Rheumatoid Factor, Export
00816057020485Detection of Rheumatoid Factor
00816057020461Detection of Rheumatoid Factor

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