Device, Parasite Concentration

Device Code: 3426

Product Code(s): LKS

Device Classification Information

• Device Type ID: 3426
• Device Name: Device, Parasite Concentration
• Regulation Description: Microbiological Specimen Collection And Transport Device.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.2900 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LKS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-191 CLSI MM13-A (Replaces MM13-P)
  Collection, Transport, Preparation, And Storage Of Specimens For Molecular Methods; Approved Guideline
• 7-250 CLSI M40-A2
  Quality Control Of Microbiological Transport Systems; Approved Standard - Second Edition.

Total Product Life Cycle

• Device Type ID: 3426
• Device: Device, Parasite Concentration
• Product Code: LKS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microbiological Specimen Collection And Transport Device.
• CFR Regulation Number: 866.2900 [🔎]

TPLC Last Update: 2019-04-02 20:29:30