Test, Vaginal, Bacterial Sialidase

Device Code: 692

Product Code(s): MXB

Device Classification Information

• Device Type ID: 692
• Device Name: Test, Vaginal, Bacterial Sialidase
• Regulation Description: Microorganism Differentiation And Identification Device.
• Regulation Medical Specialty: Microbiology
• Review Panel: Clinical Chemistry
• 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: MXB
• 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: 692
• Device: Test, Vaginal, Bacterial Sialidase
• Product Code: MXB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

TPLC Last Update: 2019-04-02 19:38:47