Culture Media, Selective Broth

Device Code: 3336

Product Code(s): JSD

Device Classification Information

• Device Type ID: 3336
• Device Name: Culture Media, Selective Broth
• Regulation Description: Selective Culture Medium.
• 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: 866.2360 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JSD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16
  Quality Control For Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
• 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: 3336
• Device: Culture Media, Selective Broth
• Product Code: JSD
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Selective Culture Medium.
• CFR Regulation Number: 866.2360 [🔎]

TPLC Last Update: 2019-04-02 20:27:50