Antigens, Nontreponemal, All

Device Code: 3168

Product Code(s): GMQ

Device Classification Information

• Device Type ID: 3168
• Device Name: Antigens, Nontreponemal, All
• Regulation Description: Treponema Pallidum Nontreponemal Test Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GMQ
• 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: 3168
• Device: Antigens, Nontreponemal, All
• Product Code: GMQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Treponema Pallidum Nontreponemal Test Reagents.
• CFR Regulation Number: 866.3820 [🔎]

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
ARLINGTON SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
GOLD STANDARD DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:24:54