Radioimmunoassay, Immunoglobulins (d, E)

Device Code: 3007

Product Code(s): JHR

Device Classification Information

• Device Type ID: 3007
• Device Name: Radioimmunoassay, Immunoglobulins (d, E)
• Regulation Description: Immunoglobulins A, G, M, D, And E 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: 866.5510 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JHR
• 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

• 7-113 CLSI I/LA23-A (Replaces I/LA23-P)
  Assessing The Quality Of Immunoassay Systems: Radioimmunoassays, And Enzyme, Fluorescence, And Luminescence Immunoassays; Approved Guideline
• 7-270 CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3)
  Analytical Performance Characteristics, Quality Assurance, And Clinical Utility Of Immunological Assays For Human Immunoglobulin E Antibodies Of Defined Allergen Specificities

Total Product Life Cycle

• Device Type ID: 3007
• Device: Radioimmunoassay, Immunoglobulins (d, E)
• Product Code: JHR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunoglobulins A, G, M, D, And E Immunological Test System.
• CFR Regulation Number: 866.5510 [🔎]

Device Problems
Low Test Results	4
High Test Results	3
Incorrect Or Inadequate Test Results	2
Total Device Problems	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics	II	Apr-25-2014

TPLC Last Update: 2019-04-02 20:22:30