Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Device Code: 3383

Product Code(s): KHW

Device Classification Information

• Device Type ID: 3383
• Device Name: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• Regulation Description: Entamoeba Histolytica Serological Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.3220 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KHW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-148 CLSI M28-A2 (Replaces M28-A)
  Procedures For The Recovery And Identification Of Parasites From The Intestinal Tract; Approved Guideline - Second Edition.

Total Product Life Cycle

• Device Type ID: 3383
• Device: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• Product Code: KHW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Entamoeba Histolytica Serological Reagents.
• CFR Regulation Number: 866.3220 [🔎]

Premarket Reviews
Manufacturer	Decision
TECHLAB, INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:28:39