Antigens, All Types, Escherichia Coli

Device Code: 3175

Product Code(s): GMZ

Device Classification Information

• Device Type ID: 3175
• Device Name: Antigens, All Types, Escherichia Coli
• Regulation Description: Escherichia Coli 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: 866.3255 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GMZ
• 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: 3175
• Device: Antigens, All Types, Escherichia Coli
• Product Code: GMZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Escherichia Coli Serological Reagents.
• CFR Regulation Number: 866.3255 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:25:03