Phages, Staphylococcal Typing, All Types

Device Code: 3318

Product Code(s): GTL

Device Classification Information

• Device Type ID: 3318
• Device Name: Phages, Staphylococcal Typing, All Types
• Regulation Description: Staphylococcal Typing Bacteriophage.
• 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: 866.2050 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GTL
• 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: 3318
• Device: Phages, Staphylococcal Typing, All Types
• Product Code: GTL
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Staphylococcal Typing Bacteriophage.
• CFR Regulation Number: 866.2050 [🔎]

TPLC Last Update: 2019-04-02 20:27:30