Product Classification

• Device: device, specimen collection
• Regulation Description: Microbiological specimen collection and transport device.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LIO
• Submission Type: 510(k)
• Regulation Number: 866.2900
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M40-A Quality Control of Microbiological Transport Systems; Approved Standard
• CLSI/NCCLS GP14-A 1996 Labeling of Home-Use In Vitro Testing Products; Approved Guideline
• CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.