Culture Media, Non-selective And Non-differential

Device Code: 3339

Product Code(s): JSG

Device Classification Information

• Device Type ID: 3339
• Device Name: Culture Media, Non-selective And Non-differential
• Regulation Description: Multipurpose 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: 866.2300 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JSG
• 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
• 7-189 CLSI M47-A (Replaces M47-P)
  Principles And Procedures For Blood Cultures; Approved Guideline

Total Product Life Cycle

• Device Type ID: 3339
• Device: Culture Media, Non-selective And Non-differential
• Product Code: JSG
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Multipurpose Culture Medium.
• CFR Regulation Number: 866.2300 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumedia Manufacturers, Inc.	III	Jun-01-2017
2	Acumedia Manufacturers, Inc.	III	Jun-01-2017
3	Acumedia Manufacturers, Inc.	II	Jan-25-2017
4	Becton Dickinson & Co.	II	Nov-30-2018
5	Becton Dickinson & Co.	III	Apr-26-2017
6	Becton Dickinson & Co.	II	Jan-14-2015
7	Remel Inc	II	Sep-07-2018
8	Remel Inc	II	Jun-10-2015

TPLC Last Update: 2019-04-02 20:27:53