Radioassay, Intrinsic Factor Blocking Antibody

Device Code: 609

Product Code(s): LIG

Device Classification Information

• Device Type ID: 609
• Device Name: Radioassay, Intrinsic Factor Blocking Antibody
• Regulation Description: Vitamin B[bdi1][bdi2] 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: 862.1810 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LIG
• 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: 609
• Device: Radioassay, Intrinsic Factor Blocking Antibody
• Product Code: LIG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Vitamin B[bdi1][bdi2] Test System.
• CFR Regulation Number: 862.1810 [🔎]

Device Problems
Leak / Splash	1
High Test Results	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:37:20