MicroTrak® 8H399UL

GUDID 05391516746144

MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test Control Slide Pack

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
Primary Device ID05391516746144
NIH Device Record Key926bb61b-a399-4b71-a8e5-acebdc1df1c5
Commercial Distribution Discontinuation2019-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMicroTrak®
Version Model Number8H399UL
Catalog Number8H399UL
Company DUNS988298840
Company NameTRINITY BIOTECH PUBLIC LIMITED COMPANY
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35312769800
EmailInfectiousdisease.techsupport@trinitybiotech.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516746144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-10
Device Publish Date2016-09-23

On-Brand Devices [MicroTrak®]

05391516748643MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit
05391516746144MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test Control Slide Pack
05391516746038MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test
05391516746007MicroTrak® HSV-1/HSV-2 Culture Identification/Typing Test

Trademark Results [MicroTrak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MICROTRAK
MICROTRAK
75060158 not registered Dead/Abandoned
Radionics Software Applications, Inc.
1996-02-20
MICROTRAK
MICROTRAK
74686723 not registered Dead/Abandoned
Hornbuckle Engineering, Inc.
1995-06-09
MICROTRAK
MICROTRAK
74377831 1854426 Dead/Cancelled
DADE BEHRING INC.
1993-04-12
MICROTRAK
MICROTRAK
74099889 1738933 Dead/Cancelled
Bell & Howell Document Management Products Company, Inc.
1990-09-21
MICROTRAK
MICROTRAK
73723357 1521633 Live/Registered
WEB PRINTING CONTROLS CO., INC.
1988-04-18
MICROTRAK
MICROTRAK
73427598 1281984 Dead/Cancelled
Syva Company
1983-05-26
MICROTRAK
MICROTRAK
73347637 not registered Dead/Abandoned
Flow Technology, Inc.
1982-01-28

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