ASI Color Mono II Test NC-450050E

GUDID 00816057020294

Detection of heterophil antibodies associated with infectious mononucleosis, Export

ARLINGTON SCIENTIFIC, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Primary Device ID00816057020294
NIH Device Record Key83581bf7-322d-4ff7-91f8-3729ed4385bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI Color Mono II Test
Version Model NumberNC-450050E
Catalog NumberNC-450050E
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
GS100816057020294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTNSystem, Test, Infectious Mononucleosis

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 Color Mono II Test]

00816057020324Detection of heterophil antibodies associated with infectious mononucleosis
00816057020317Detection of heterophil antibodies associated with infectious mononucleosis, Export
00816057020300Detection of heterophil antibodies associated with infectious mononucleosis
00816057020294Detection of heterophil antibodies associated with infectious mononucleosis, Export
00816057020287Detection of heterophil antibodies associated with infectious mononucleosis
00816057020270Detection of heterophil antibodies associated with infectious mononucleosis, Export
00816057020263Detection of heterophil antibodies associated with infectious mononucleosis

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