ASI SLE Slide Test NC-350025

GUDID 00816057020195

Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

ARLINGTON SCIENTIFIC, INC.

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Primary Device ID00816057020195
NIH Device Record Keydcf92bde-6f03-4741-bce9-aefbad121124
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI SLE Slide Test
Version Model NumberNC-350025
Catalog NumberNC-350025
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
GS100816057020195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHCSystem, Test, Systemic Lupus Erythematosus

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 SLE Slide Test]

00816057020256Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
00816057020249Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
00816057020232Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
00816057020225Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
00816057020218Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
00816057020201Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
00816057020195Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

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