Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment

Device Code: 3401

Product Code(s): LHW

Device Classification Information

• Device Type ID: 3401
• Device Name: Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
• Regulation Description: Streptococcus Spp. Exoenzyme 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: 866.3720 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LHW
• 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: 3401
• Device: Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
• Product Code: LHW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Streptococcus Spp. Exoenzyme Reagents.
• CFR Regulation Number: 866.3720 [🔎]

Device Problems
False Negative Result	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:29:03