Antisera, Fluorescent, Histoplasma Capsulatum

Device Code: 3163

Product Code(s): GML

Device Classification Information

• Device Type ID: 3163
• Device Name: Antisera, Fluorescent, Histoplasma Capsulatum
• Regulation Description: Histoplasma Capsulatum 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: 866.3320 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GML
• 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: 3163
• Device: Antisera, Fluorescent, Histoplasma Capsulatum
• Product Code: GML
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Histoplasma Capsulatum Serological Reagents.
• CFR Regulation Number: 866.3320 [🔎]

TPLC Last Update: 2019-04-02 20:24:49