GLOBULIN REAGENT (SEE ATTACHED DESCRIPTIVE MATERIAL) 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	JGE
FDA Classification Name	TURBIDIMETRIC METHOD, GLOBULIN
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1330
FDA Common Generic Name	COPPER SULFATE - ACID REAGENT FOR COLORIMETRIC DETERMINATION OF GLOBULIN
FDA Proprietary Device Name	GLOBULIN REAGENT (SEE ATTACHED DESCRIPTIVE MATERIAL)
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 113 THYMOL	REAGENT THYMOL
2	ROWLEY BIOCHEMICAL INSTITUTE, INC. 10 ELECTRONICS AVE. DANVERS INDUSTRIAL PARK DANVERS, MA 01923 US 978-739-4883 / 978-739-4883	MULTIPLE	SERUM THYMOL TURBIDITY AND ZINC SULFATE TURBIDITY