Alethia™ HSV 1&2 External Control Kit 479960

GUDID 00840733102158

The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.

MERIDIAN BIOSCIENCE, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Primary Device ID00840733102158
NIH Device Record Key8ea1134d-a143-4540-8793-8e752ddf7649
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlethia™ HSV 1&2 External Control Kit
Version Model Number479960
Catalog Number479960
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733102158 [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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