Autoantibodies, Endomysial(tissue Transglutaminase)

Device Code: 3055

Product Code(s): MVM

Device Classification Information

• Device Type ID: 3055
• Device Name: Autoantibodies, Endomysial(tissue Transglutaminase)
• Regulation Description: Multiple Autoantibodies 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: 866.5660 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MVM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3055
• Device: Autoantibodies, Endomysial(tissue Transglutaminase)
• Product Code: MVM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Multiple Autoantibodies Immunological Test System.
• CFR Regulation Number: 866.5660 [🔎]

Premarket Reviews
Manufacturer	Decision
PHADIA AB
	SUBSTANTIALLY EQUIVALENT	1
SQI DIAGNOSTICS SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:23:10