Lipoprotein, Low-density, Antigen, Antiserum, Control

Device Code: 2967

Product Code(s): DFC

Device Classification Information

• Device Type ID: 2967
• Device Name: Lipoprotein, Low-density, Antigen, Antiserum, Control
• Regulation Description: Low-density Lipoprotein Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.5600 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DFC
• 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

• 7-175 CLSI C59-A
  Apoplipoprotein Immunoassays: Development And Recommended Performance Characteristics; Approved Guideline

Total Product Life Cycle

• Device Type ID: 2967
• Device: Lipoprotein, Low-density, Antigen, Antiserum, Control
• Product Code: DFC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Low-density Lipoprotein Immunological Test System.
• CFR Regulation Number: 866.5600 [🔎]

Premarket Reviews
Manufacturer	Decision
DIAZYME LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Low Test Results	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:21:52