MTS Doxycycline 0.016 - 256 µg/mL

• K Number: K190914
• Device Name: MTS Doxycycline 0.016 - 256 µg/mL
• Manufacturer: Liofilchem s. r. l.
• Date Cleared: 2019-05-29 ( 51 days)
• Product Code: JWY
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA clearance letter for a device named "MTS Doxycycline 0.016 - 256 µg/mL" and mainly discusses regulatory matters and compliance.

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).