UREA NITROGEN TEST SET 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	CDW
FDA Classification Name	DIACETYL-MONOXIME, UREA NITROGEN
FDA Device Classification Code	Standards
FDA Regulation Number	862.1770
FDA Common Generic Name	DIACETYL MONOXIME/THIOSEMICARBAZIDE PROCEDURE FOR UREA NITROGEN
FDA Proprietary Device Name	UREA NITROGEN TEST SET
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	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
2	DIAGNOSTIC SPECIALTIES 4 LEONARD ST. METUCHEN, NJ 08840 US 732-549-4011 / 732-549-4011	UREA NITROGEN REAGENT	UREA NITROGEN REAGENT
3	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 131 UREA NITROGEN	REAGENT UREA NITROGEN
4	DREW SCIENTIFIC, INC. 353 CHRISTIAN ST. OXFORD, CT 06484 US 214-210-4937 / 214-210-4937	UREA NITROGEN REAGENT SET	UREA NITROGEN REAGENT SET
5	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	DIACETHYL-MONOXIME, UREA NITROGEN
6	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	DIACETYL MONOXIME, UREA NITROGEN
7	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	DIACETYL-MONOXIME, UREA NITROGEN	DIACETYL-MONOXIME, UREA NITROGEN
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
9	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		UREA NITROGEN REAGENT SET