MicroTrak®

Basic Information

• Brand Name: MicroTrak®
• Primary DI: 05391516746144
• Version / Model: 8H399UL
• Catalog Number: 8H399UL
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Labeler DUNS: 988298840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2019-05-10
• Public Version Status: Update
• Public Device Record Key: 926bb61b-a399-4b71-a8e5-acebdc1df1c5
• Distribution End Date: 2019-01-01

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Microbiology	866.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52840	Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516746144	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10 Slides

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius