LBA AFP-L3, AFP-L3 CALIBRATOR SET AFP-L3 CONTROL SET MANUFACTURED BY WAKO PURE CHEMICAL INDUSTRIES, LTD.

Please Login or Create an Account Now.

This company has been viewed 53 times within the past 60 days.

This product has been viewed: 36 times.

Request for Information Form	Contact Information
Company Name	WAKO PURE CHEMICAL INDUSTRIES, LTD.
Address	2613-2 OAZA OGOHARA KOMONO-CHO
City, State, Zip	MIE,
Country	JA
FDA Owner/Operator Phone	816-620-33741
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	NSF
FDA Classification Name	TEST, ALPHA FETOPROTEIN L3 SUBFRACTION (AFP-L3%), FOR HEPATOCELLULAR CARCINOMA RISK ASSESSMENT
FDA Device Classification Code	Standards
FDA Regulation Number	866.6030
FDA Common Generic Name	AFP TEST KIT & AFP STANDARD
FDA Proprietary Device Name	LBA AFP-L3, AFP-L3 CALIBRATOR SET AFP-L3 CONTROL SET
FDA Owner / Operator Number	8030234
FDA Owner / Operator Name	WAKO PURE CHEMICAL INDUSTRIES, LTD.
FDA Establishment Registration Number	3003522182
FDA Registered Establishment Name	WAKO PURE CHEMICAL INDUSTRIES, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-02-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109	AFP DIFFERENTIAL KIT, AFP-L3% TEST, AFP STANDARD	AFP TEST KIT & AFP STANDARD
2	WAKO PURE CHEM., DIAG. RESEARCH LABS 6-1 TAKADA-CHO AMAGASAKI, HYOGO-KEN, 661-0963 JA 816-620-33741 / 650-210-9153 109	AFP DIFFERENTIAL KIT, AFP-L3% TEST, AFP STANDARD	AFP TEST KIT & AFP STANDARD