Berthelot Indophenol, Urea Nitrogen

Device Code: 247

Product Code(s): CDL

Device Classification Information

• Device Type ID: 247
• Device Name: Berthelot Indophenol, Urea Nitrogen
• Regulation Description: Urea Nitrogen 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)
• CFR Regulation Number: 862.1770 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CDL
• 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: 247
• Device: Berthelot Indophenol, Urea Nitrogen
• Product Code: CDL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Urea Nitrogen Test System.
• CFR Regulation Number: 862.1770 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Sterling Diagnostics, Inc.	III	Dec-29-2016

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