STANBIO TRI-LEVEL HEMOGLOBIN CONTROL SET MANUFACTURED BY STANBIO LABORATORY

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STANBIO TRI-LEVEL HEMOGLOBIN CONTROL SET

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	HE - Hematology
FDA Product Code	GGM
FDA Classification Name	CONTROL, HEMOGLOBIN
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
FDA Common Generic Name	HUMAN HEMOGLOBIN CONTROLS FOR QUANTITATIVE CYANMETHEMOGLOBIN
FDA Proprietary Device Name	STANBIO TRI-LEVEL HEMOGLOBIN CONTROL 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)	RR - Repackager/Relabeller
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of STANBIO LABORATORY

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	BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200	LYPHOCHEK HEMOGLOBIN	LYPHOCHEK HEMOGLOBIN
2	CHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK RD. MEDFORD, NY 11763 US 631-924-1135 / 631-924-1135	SICKLE-STAT CONTROL	SICKLING HEMOGLOBIN CONTROLS
3	CONE BIOPRODUCTS 1012 N. AUSTIN ST. SEGUIN, TX 78155 US 830-372-1690 22 / 830-379-0197 203	MULTIPLE	HEMOGLOBIN A1C LINEARITY SET
4	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	SICKLE-TROL	SICKLE-CELL HEMOGLOBIN CONTROLS
5	DREW SCIENTIFIC CO. LIMITED UNIT 4 PETER GREEN WAY,FURNESS ENTERPRISE BUSINESS PARK BARROW-IN-FURNESS, CUMBRIA, LA14 2PE UK 214-210-4937 / 44-12-29 432089	DREW GLYCATED HB CONTROL KIT	HBA1C CONTROL KIT
6	EUROTROL B.V. KEPLERLAAN 20 EDE, NL 6716 BS NL 313-186-95777 / 978-274-5011	MULTIPLE	HEMOGLOBIN CONTROL
7	EUROTROL US, B.V. KEPLERLAAN 20 EDE, 6716BS NL 31-318-695777 / 866-234-5754	HEMOCUE HEMOLIN, HEMOCUE HEMOTROL	HEMOGLOBIN QUALITY CONTROL, HEMOGLOBIN TEST QUALITY CONTROL
8	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	PACIFIC HEMOSTASIS UCRP & ACRP	NORMAL AND ABNORMAL COAGULATION REFERENCE PLASMA
9	HEMOCUE AB KUVETTGATAN 1 ANGELHOLM, SE-262 71 SW 464-314-5 82 00 / 800-881-1611 110	HEMOCUE PLASMA/LOW HEMOGLOBIN CONTROLS	PLASMA HEMOGLOBIN CONTROLS
10	INTERNATIONAL REAGENTS CORP. SANNOMIYA KOKUSAI BUILDING 1-30 HAMABE-DORI 2-CHOME CHUO-KU, KOBE, 651 JA 078-231-4151 / 078-231-4151	GLYCO HB CONTROL	GLYCO HEMOGLOBIN CONTROL
11	MEDION DIAGNOSTICS AG BONNSTRASSE 9 DUEDINGEN, CH-3186 SZ 41-26-4928535 / 41-26-492 8535	SICKLE TROL	HEMOGLOBIN CONTROL
12	SANDARE INTL., INC. 910 K.C.K. WAY CEDAR HILL, TX 75104 US 972-293-7440 / 972-293-7440	SANDARE HEMOGLOBIN CONTROLS	HEMOGLOGIN CONTROLS
13	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIGENT HEMOGLOBIN CONTROLS	HEMOGLOBIN CONTROLS