Antisera, Fluorescent, Cryptococcus Neoformans

Device Code: 3157

Product Code(s): GME

Device Classification Information

• Device Type ID: 3157
• Device Name: Antisera, Fluorescent, Cryptococcus Neoformans
• Regulation Description: Cryptococcus Neoformans 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: 866.3165 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GME
• 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: 3157
• Device: Antisera, Fluorescent, Cryptococcus Neoformans
• Product Code: GME
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cryptococcus Neoformans Serological Reagents.
• CFR Regulation Number: 866.3165 [🔎]

TPLC Last Update: 2019-04-02 20:24:44