MONOSPOT Latex 776150

GUDID 00840733101298

MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma.

MERIDIAN BIOSCIENCE, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Primary Device ID00840733101298
NIH Device Record Key3527f115-3b53-4715-a1b6-6154ebfa72bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMONOSPOT Latex
Version Model Number776150
Catalog Number776150
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone513-271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101298 [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 Date2016-09-23

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