6% O-TOLUIDINE MANUFACTURED BY POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.

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Request for Information Form	Contact Information
Company Name	POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.
Address	70 CLEVELAND AVE.
City, State, Zip	BAY SHORE, NY 11706
Country	US
FDA Owner/Operator Phone	631-586-0400
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGE
FDA Classification Name	ORTHOTOLUIDINE, GLUCOSE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1345
FDA Common Generic Name	6% O-TOLUIDINE
FDA Proprietary Device Name	6% O-TOLUIDINE
FDA Owner / Operator Number	2429783
FDA Owner / Operator Name	POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.
FDA Establishment Registration Number	2429783
FDA Registered Establishment Name	POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.
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	DIAGNOSTIC SPECIALTIES 4 LEONARD ST. METUCHEN, NJ 08840 US 732-549-4011 / 732-549-4011	GLUCOSE REAGENT SET	GLUCOSE REAGENT SET
2	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 159 BLOOD SUGAR	REAGENT GLUCOSE
3	DREW SCIENTIFIC, INC. 353 CHRISTIAN ST. OXFORD, CT 06484 US 214-210-4937 / 214-210-4937	DIRECT GLUCOSE REAGENT SET	GLUCOSE REAGENT SET
4	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	ORTHOTOLUIDIDNE GLUCOSE
5	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	GLUCOSE SET	GLUCOSE SET
6	HEALTH CARE LOGISTICS, INC. 3605 URBANCREST INDUSTRIAL DR. GROVE CITY, OH 43123 US 800-848-1633 / 800-848-1633	SAFESTRIP BLOOD GLUCOSE TEST SYRINGE	STERILE DIABETIC TEST SYRINGE
7	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	ORTHOTOLUIDINE, GLUCOSE	ORTHOTOLUIDINE, GLUCOSE
8	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	ORTHO-TOLUIDINE, FROM NITRATE (SEE ATTACHED DESCRIPTIVE MATE	ORTHO-TOLUIDINE, FROM NITRATE (SEE ATTACHED DESCRIPTIVE MATERIAL)