Enzyme Immunoassay, Inhibin-a

Device Code: 631

Product Code(s): NDR

Device Classification Information

• Device Type ID: 631
• Device Name: Enzyme Immunoassay, Inhibin-a
• Regulation Description: Estradiol Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1260 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NDR
• 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: 631
• Device: Enzyme Immunoassay, Inhibin-a
• Product Code: NDR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Estradiol Test System.
• CFR Regulation Number: 862.1260 [🔎]

Device Problems
High Test Results	11
Total Device Problems	11

TPLC Last Update: 2019-04-02 19:37:51