Direct Agglutination Test, Toxoplasma Gondii

Device Code: 3428

Product Code(s): LLA

Device Classification Information

• Device Type ID: 3428
• Device Name: Direct Agglutination Test, Toxoplasma Gondii
• Regulation Description: Toxoplasma Gondii 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: 866.3780 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LLA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-182 CLSI M36-A
  Clinical Use And Interpretation Of Serologic Tests For Toxoplasma Gondii; Approved Guideline.

Total Product Life Cycle

• Device Type ID: 3428
• Device: Direct Agglutination Test, Toxoplasma Gondii
• Product Code: LLA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Toxoplasma Gondii Serological Reagents.
• CFR Regulation Number: 866.3780 [🔎]

TPLC Last Update: 2019-04-02 20:29:37