Antisera, Fluorescent, All Groups, Streptococcus Spp.

Device Code: 3324

Product Code(s): GTX

Device Classification Information

• Device Type ID: 3324
• Device Name: Antisera, Fluorescent, All Groups, Streptococcus Spp.
• Regulation Description: Streptococcus Spp. Serological Reagents.
• 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: 866.3740 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GTX
• 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: 3324
• Device: Antisera, Fluorescent, All Groups, Streptococcus Spp.
• Product Code: GTX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Streptococcus Spp. Serological Reagents.
• CFR Regulation Number: 866.3740 [🔎]

TPLC Last Update: 2019-04-02 20:27:38