SENSITITRE NEPHELOMETER

Basic Information

• Brand Name: SENSITITRE NEPHELOMETER
• Primary DI: 05032384474516
• Version / Model: V3011
• Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 298203498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-14
• Public Version: 1
• Public Version Date: 2022-12-22
• Public Version Status: New
• Public Device Record Key: 85a0100c-b354-4f9a-9ced-a1425a1eb8a2

Device Description

The Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in suspension and detected by a photodiode. The quantity of scattered light is compared with a reference value obtained by calibrating the Nephelometer with a 0.5 McFarland turbidity standard.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JQX	Nephelometer, For Clinical Use	Clinical Chemistry	862.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57870	Microorganism-density nephelometer IVD	A mains electricity (AC-powered) laboratory instrument intended to be used to determine the density of microorganism suspensions by comparing the turbidity of a solution with that of McFarland standards using a photometric detection system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384474516	GS1

Customer Contacts

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