Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

Device Code: 3369

Product Code(s): JTZ

Device Classification Information

• Device Type ID: 3369
• Device Name: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.1700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JTZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-236 CLSI M43-A
  Methods For Antimicrobial Susceptibility Testing For Human Mycoplasmas; Approved Guideline.
• 7-262 CLSI M45 3rd Edition
  Methods For Antimicrobial Dilution And Disk Susceptibility Testing Of Infrequently Isolated Or Fastidious Bacteria.

Total Product Life Cycle

• Device Type ID: 3369
• Device: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
• Product Code: JTZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• CFR Regulation Number: 866.1700 [🔎]

Premarket Reviews
Manufacturer	Decision
EDGE BIOLOGICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Remel Inc	II	Dec-07-2017
2	Thermo Fisher	II	Jun-08-2018

TPLC Last Update: 2019-04-02 20:28:20