Dna Probe, Trichomonas Vaginalis

Device Code: 3494

Product Code(s): MJK

Device Classification Information

• Device Type ID: 3494
• Device Name: Dna Probe, Trichomonas Vaginalis
• Regulation Description: Microorganism Differentiation And Identification Device.
• 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: 866.2660 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MJK
• GMP Exempt: No
• 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: 3494
• Device: Dna Probe, Trichomonas Vaginalis
• Product Code: MJK
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

Device Problems
Device Operates Differently Than Expected	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:31:08