HEMOPOINT H2 HEMOGLOBIN CONTROLS MANUFACTURED BY STANBIO LABORATORY

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HEMOPOINT H2 HEMOGLOBIN CONTROLS

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	JPK
FDA Classification Name	MIXTURE, HEMATOLOGY QUALITY CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
FDA Common Generic Name	HEMOGLOBIN CONTROLS
FDA Proprietary Device Name	HEMOPOINT H2 HEMOGLOBIN CONTROLS
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	10-25-05
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	AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. CARLSBAD, CA 92008 US 760-431-7922 / 760-431-7922	GLYCATED HEMOGLOBIN AIC CONTROLS	GLYCATED HEMOGLOBIN AIC CONTROLS
2	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	HEMOGLOB AF/SC ELECTROPHORESIS CONTROL
3	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	HEMATOLOGY QUALITY CONTROL MIXTURE
4	BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099	QBC HEMATOLOGY CONTROL	QBC HEMATOLOGY CONTROL
5	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US 978-772-7070 / 978-772-7070 220	RNA MEDICAL HEMOGLOBIN CONTROL FOR HEMOCUE ANALYZERS	HEMOGLOBIN CONTROL
6	BIO-RAD LABORATORIES, DIAGNOSTIC GROUP 524 STONE RD. SUITE A BENICIA, CA 94510 US 510-724-7000 / 949-598-1280	MULTIPLE	HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
7	BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200	MULTIPLE	HEMATOLOGY QUALITY CONTROL
8	BOULE MEDICAL AB VASTBERGA ALLE' 32 P.O. BOX 42056 STOCKHOLM, SE-126 13 SW 468-744-7700 / 468-744-7700	CDS 3PD HEMATOLOGY QUALITY CONTROL	CONTROL FOR HEMATOLOGY ANALYZERS THAT PERFORM 3 PART DIFFS
9	CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1800 N.W. 65TH AVE. PLANTATION, FL 33313 US 468-744-7700 / 954-791-1773	CDS-5PH HEMATOLOGY CONTROL	CONTROL FOR HEMATOLOGY ANALYQERS THAT PERFORM 5 PART DIFFS.
10	DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949	LASER-CAL TM	MULTI-PARAMETER HEMATOLOGY CALIBRATOR FOR LASER/OPTIC INSTRUMENTS
11	EUROPEAN CONCERTED ACTION ON ANTICOAGULATION STOPFORD BLDG. UNIVERSTIY OF MANCHESTER MANCHESTER, M13 9PT UK 161-275-5316 / 44-161-2755316	"POLLER CALIBRANTS"	CERTIFIED LYOPHILISED PLASMAS
12	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	VARIOUS TYPES OF BLOOD CONTROL
13	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	MULTIPLE	HEMATOLOGY QUALITY CONTROL MIXTURE
14	IRIS DIAGNOSTICS 9172 ETON AVE. CHATSWORTH, CA 91311 US 818-709-1244 7129 / 818-709-1244 7129	IQ BODY FLUIDS CONTROLS-LEVEL I AND LEVEL II	CONTROLS
15	MEDTRO GMBH 2 HOEHENSTRASSE LEIMEN-GAV, 69181 GM 06-226-8778 / 06-226-8778	THROMBO-TEST	MEDTRO-TEST
16	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	STAT PROFILE PHOX ANALYZERS, STAT PROFILE ULTRA ANALYZERS	BLOOD GAS-PH ANALYZERS
17	QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. REDONDO BEACH, CA 90278 US 310-536-0006 / 310-536-0006	SYNOVIAL SCOPICS, SYNOVIAL FLUID CONTROL	SYNOVIAL FLUID CONTROL
18	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413	HEMATOLOGY CONTROL	HEMATOLOGY CONTROL MATERIAL
19	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
20	STRECK 7002 SOUTH 109TH ST. OMAHA, NE 68128 US 800-843-0912 / 402-537-5313	MULTIPLE PRODUCTS	MULTIPLE INSTRUMENTS
21	TRILLIUM DIAGNOSTICS, LLC. 915 UNION ST., SUITE 3 BANGOR, ME 04401 US 207-945-0900 / 207-945-0900	FETALTROL	FETALTROL RED CELL CONTROL
22	VEGAMED, INC. EDIFICIO MULTIFABRIL #5 AVE. LAS FLORES #39 VEGA BAJA, PR 00693 US 787-807-0392 / 787-807-0392	BRU-HEMATROL 8	HEMATOLOGY CONTROL