Alethia™ Pertussis External Control Kit 479930

GUDID 00840733102141

The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

MERIDIAN BIOSCIENCE, INC.

Bordetella pertussis nucleic acid IVD, control
Primary Device ID00840733102141
NIH Device Record Keyd416009a-95dd-46e8-ad33-1100db71951a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlethia™ Pertussis External Control Kit
Version Model Number479930
Catalog Number479930
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
GS100840733102141 [Primary]

FDA Product Code

OZZBordetella Pertussis Dna Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-08
Device Publish Date2019-01-08

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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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