Alethia™ HSV 1&2 480650

GUDID 00840733102219

The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.

MERIDIAN BIOSCIENCE, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840733102219
NIH Device Record Keyf0049e4c-9066-49cc-bfac-ec8824adaed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlethia™ HSV 1&2
Version Model Number480650
Catalog Number480650
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

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733102219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-11
Device Publish Date2019-01-09

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Trademark Results [Alethia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALETHIA
ALETHIA
87621403 5710741 Live/Registered
Meridian Bioscience, Inc.
2017-09-25
ALETHIA
ALETHIA
78324275 not registered Dead/Abandoned
Alethia Alpha Omega
2003-11-06
ALETHIA
ALETHIA
77819996 3998752 Live/Registered
ALETHIA SKIN CARE LLC
2009-09-03
ALETHIA
ALETHIA
77476850 not registered Dead/Abandoned
Falbo, Alexander A.
2008-05-16
ALETHIA
ALETHIA
77476850 not registered Dead/Abandoned
Falbo, Anthony E.
2008-05-16
ALETHIA
ALETHIA
76611528 not registered Dead/Abandoned
Axios Wine, Inc.
2004-09-10
ALETHIA
ALETHIA
75690715 not registered Dead/Abandoned
Commercial Electronics, LLC
1999-04-23

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