Ige, Antigen, Antiserum, Control

Device Code: 2983

Product Code(s): DGC

Device Classification Information

• Device Type ID: 2983
• Device Name: Ige, Antigen, Antiserum, Control
• 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: DGC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 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: 2983
• Device: Ige, Antigen, Antiserum, Control
• Product Code: DGC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunoglobulins A, G, M, D, And E Immunological Test System.
• CFR Regulation Number: 866.5510 [🔎]

Premarket Reviews
Manufacturer	Decision
PHADIA AB
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Adverse Event Without Identified Device Or Use Problem	3
Insufficient Information	2
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Total Device Problems	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Randox Laboratories Ltd.	II	Oct-06-2016
2	Tosoh Bioscience Inc	II	Jun-05-2018

TPLC Last Update: 2019-04-02 20:22:06