CHOLESTEROL REAGENT MANUFACTURED BY STANBIO LABORATORY

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Request for Information Form	Contact Information
Company Name	STANBIO LABORATORY
Address	1261 NORTH MAIN ST.
City, State, Zip	BOERNE, TX 78006
Country	US
FDA Owner/Operator Phone	830-249-0772
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGO
FDA Classification Name	LIEBERMAN-BURCHARD/ABELL-KENDALL, COLORIMETRIC, CHOLESTEROL
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1175
FDA Common Generic Name	CLASSICAL LIEBERMAN-BURCHARD CHOLESTEROL REAGENT
FDA Proprietary Device Name	CHOLESTEROL REAGENT
FDA Owner / Operator Number	1616487
FDA Owner / Operator Name	STANBIO LABORATORY
FDA Establishment Registration Number	1616487
FDA Registered Establishment Name	STANBIO LABORATORY
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
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	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 125 CHOLESTEROL	REAGENT CHOLESTEROL
2	EGYPTIAN CO. FOR BIOTECHNOLOGY BLDG 19A, BLOCK 20008, STREET 163 OBOUR CITY, CAIRO, EG 2-02-6651848 / 2-02-6651848	SPECTRUM DIAGNOSTICS TOT. CHOLESTEROL SYSTEM	TOTAL CHOLESTEROL TEST SYSTEM
3	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	CHOLESTEROL REAGENT SET	CHOLESTEROL REAGENT SET
4	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	LIEBERMAN-BURCHARD/ABELL-KENDALL, COLORIMETRIC, CHOLESTEROL	LIEBERMAN-BURCHARD/ABELL-KENDALL, COLORIMETRIC, CHOLESTEROL
5	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	CHOLESTEROL	CHOLESTEROL
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE