Culture Media, Selective And Non-differential

Device Code: 3342

Product Code(s): JSJ

Device Classification Information

• Device Type ID: 3342
• Device Name: Culture Media, Selective And Non-differential
• 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: JSJ
• 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

Total Product Life Cycle

• Device Type ID: 3342
• Device: Culture Media, Selective And Non-differential
• Product Code: JSJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Selective Culture Medium.
• CFR Regulation Number: 866.2360 [🔎]

Device Problems
False Negative Result	2
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumedia Manufacturers, Inc.	III	Oct-26-2018
2	Hardy Diagnostics	II	Apr-26-2016

TPLC Last Update: 2019-04-02 20:27:56