Kit, Direct Antigen, Positive Control

Device Code: 3148

Product Code(s): MJZ

Device Classification Information

• Device Type ID: 3148
• Device Name: Kit, Direct Antigen, Positive Control
• Regulation Description: Quality Control Material (assayed And Unassayed).
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1660 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MJZ
• 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: 3148
• Device: Kit, Direct Antigen, Positive Control
• Product Code: MJZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Quality Control Material (assayed And Unassayed).
• CFR Regulation Number: 862.1660 [🔎]

TPLC Last Update: 2019-04-02 20:24:35