ASI ASO Slide Test NC-300050E

GUDID 00816057020157

Detection of Anti-Streptolysin-O, Export

ARLINGTON SCIENTIFIC, INC.

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Primary Device ID00816057020157
NIH Device Record Key4e5f4fcb-ade1-40af-a982-ab596715bbaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI ASO Slide Test
Version Model NumberNC-300050E
Catalog NumberNC-300050E
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
GS100816057020157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GTOAnti-Streptokinase

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 ASO Slide Test]

00816057020188Detection of Anti-Streptolysin-O
00816057020171Detection of Anti-Streptolysin-O, Export
00816057020164Detection of Anti-Streptolysin-O
00816057020157Detection of Anti-Streptolysin-O, Export
00816057020140Detection of Anti-Streptolysin-O
00816057020133Detection of Anti-Strptolysin-O, Export
00816057020126Detection of Anti-Streptolysin O

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