Sensititre

Basic Information

• Brand Name: Sensititre
• Primary DI: M578GPALL1F2
• Version / Model: GPALL1F
• Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 298203498
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2025-03-31
• Public Version Status: Update
• Public Device Record Key: 36abb310-278f-468b-b181-d4d752dfacd5
• Distribution End Date: 2025-03-28

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63869	Multiple antibacterial susceptibility testing kit IVD	A collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M578GPALL1F2	HIBCC
Unit of Use	M578GPALL1F0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073558	000