SICKLE-STAT CONTROL MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC.

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SICKLE-STAT CONTROL

Request for Information Form	Contact Information
Company Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Address	3661 HORSEBLOCK RD.
City, State, Zip	MEDFORD, NY 11763
Country	US
FDA Owner/Operator Phone	631-924-1135
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	SICKLING HEMOGLOBIN CONTROLS
FDA Proprietary Device Name	SICKLE-STAT CONTROL
FDA Owner / Operator Number	2431980
FDA Owner / Operator Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
FDA Establishment Registration Number	2431980
FDA Registered Establishment Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
FDA Operation Code(s)	MM - Manufacturer 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 CHEMBIO DIAGNOSTIC SYSTEMS, INC.

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	CONE BIOPRODUCTS 1012 N. AUSTIN ST. SEGUIN, TX 78155 US 830-372-1690 22 / 830-379-0197 203	MULTIPLE	HEMOGLOBIN A1C LINEARITY SET
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	SICKLE-TROL	SICKLE-CELL HEMOGLOBIN CONTROLS
4	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
5	EUROTROL B.V. KEPLERLAAN 20 EDE, NL 6716 BS NL 313-186-95777 / 978-274-5011	MULTIPLE	HEMOGLOBIN CONTROL
6	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
7	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
8	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
9	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
10	MEDION DIAGNOSTICS AG BONNSTRASSE 9 DUEDINGEN, CH-3186 SZ 41-26-4928535 / 41-26-492 8535	SICKLE TROL	HEMOGLOBIN CONTROL
11	SANDARE INTL., INC. 910 K.C.K. WAY CEDAR HILL, TX 75104 US 972-293-7440 / 972-293-7440	SANDARE HEMOGLOBIN CONTROLS	HEMOGLOGIN CONTROLS
12	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIGENT HEMOGLOBIN CONTROLS	HEMOGLOBIN CONTROLS
13	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	STANBIO TRI-LEVEL HEMOGLOBIN CONTROL SET	HUMAN HEMOGLOBIN CONTROLS FOR QUANTITATIVE CYANMETHEMOGLOBIN