ASI RF Direct Slide Test NC-700100DC-E

GUDID 00816057020492

Detection fo Rheumatoid Factor, Export

ARLINGTON SCIENTIFIC, INC.

Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination Rheumatoid factor IVD, kit, agglutination
Primary Device ID00816057020492
NIH Device Record Keyfa1b4f43-fee1-47de-8915-3482f5c191a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI RF Direct Slide Test
Version Model NumberNC-700100DC-E
Catalog NumberNC-700100DC-E
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
GS100816057020492 [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

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