Antisera, Fluorescent, Chlamydia Spp.

Device Code: 3424

Product Code(s): LKI

Device Classification Information

• Device Type ID: 3424
• Device Name: Antisera, Fluorescent, Chlamydia Spp.
• Regulation Description: Chlamydia Serological Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3120 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LKI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3424
• Device: Antisera, Fluorescent, Chlamydia Spp.
• Product Code: LKI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Chlamydia Serological Reagents.
• CFR Regulation Number: 866.3120 [🔎]

TPLC Last Update: 2019-04-02 20:29:28