Radioimmunoassay, Thyroxine-binding Globulin

Device Code: 262

Product Code(s): CEE

Device Classification Information

• Device Type ID: 262
• Device Name: Radioimmunoassay, Thyroxine-binding Globulin
• Regulation Description: Thyroxine-binding Globulin 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: 862.1685 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CEE
• 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

Total Product Life Cycle

• Device Type ID: 262
• Device: Radioimmunoassay, Thyroxine-binding Globulin
• Product Code: CEE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Thyroxine-binding Globulin Test System.
• CFR Regulation Number: 862.1685 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics, Inc.	II	May-19-2015

TPLC Last Update: 2019-04-02 19:31:46