Research Use Only/microbiology

Device Code: 3620

Product Code(s): OTT

Definition: For Research Use Only And For Products Imported Into The US Only.

Device Classification Information

• Device Type ID: 3620
• Device Name: Research Use Only/microbiology
• Physical State: N/A
• Technical Method: N/A
• Target Area: N/A
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: Enforcement Discretion
• FDA Device Classification: Class Not Classified Medical Device
• Product Code: OTT
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3620
• Device: Research Use Only/microbiology
• Product Code: OTT

Recalls
Manufacturer		Recall Class	Date Posted
1	Focus Diagnostics Inc	II	Nov-06-2015

TPLC Last Update: 2019-04-02 20:33:19