COAGUCHEK XS PT CONTROLS MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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COAGUCHEK XS PT CONTROLS

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	NONNENWALD 2
City, State, Zip	PENZBERG,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GGN
FDA Classification Name	PLASMA, COAGULATION CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	864.5425
FDA Common Generic Name	COAGULATION CONTROLS
FDA Proprietary Device Name	COAGUCHEK XS PT CONTROLS
FDA Owner / Operator Number	9036646
FDA Owner / Operator Name	ROCHE DIAGNOSTICS GMBH MANNHEIM
FDA Establishment Registration Number	9610529
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-07-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS GMBH

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	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS COAGULATION CONTROLS
2	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS COAGULATION CONTROLS
3	AKERS BIOSCIENCES, INC. 201 GROVE RD. THOROFARE, NJ 08086 US 856-848-8698 / 856-848-8698	HEPARIN-PLATELET FACTOR 4 ANTIBODY SERUM PANEL	SERUM PANEL CONTROLS
4	AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777	PLASMA, COAGULATION CONTROL	COAGULATION CONTROL PLASMA (VARIOUS)
5	BIO RESEARCH CANADA, INC. 6-255 SPINNAKER WAY CONCORD, ONTARIO, L4K 4J1 CA 905-760-0232 / 905-760-0232	MULTIPLE	VARIOUS
6	BIO/DATA CORP. 155 GIBRALTAR RD. HORSHAM, PA 19044 US 215-441-4000 / 215-441-4000	CITREX II, CONTROL PLASMA, LEVEL II	COAGULATION CONTROL PLASMA
7	BIOMEDICA DIAGNOSTICS INC. 94 WENTWORTH RD. WINSOR, NOVA SCOTIA, BON 2TO CA 902-798-5105 / 714-672-3553	QUIKCOAG, VITAL, TECCOAG, HEMODIAGNOSTICA	COAGULATION CONTROLS PLASMA
8	BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200	LYPHOCHEK COAGULATION CONTROL	COAGULATION CONTROL
9	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423	TRIAGE D-DIMER CALIBRATION VERIFICATION CONTROLS AND TRIAGE D-DIMER CONTROLS	SINGLE ANALYTE CONTROL - D-DIMER
10	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	CI-TROL HEPARIN CONTROLS LOW AND HIGH	CI-TROL HEPARIN CONTROLS LOW AND HIGH
11	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	COAG CONTROL N + P, STAR - COAG CONTROL N + P	CONTROL FOR CLOTTING TESTS
12	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	COAG CONTROL N + P, STAR - COAG CONTROL N + P	CONTROL FOR CLOTTING TESTS
13	GEORGE KING BIO-MEDICAL, INC. 11771 WEST 112TH ST. OVERLAND PARK, KS 66210 US 913-469-5464 / 913-469-5464	POOLED NORMAL PLASMA, FACT, AFACT BFACT	POOLED NORMAL PLASMA, CONTROLS
14	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	PLASMA, COAGULATION CONTROL	PLASMA, COAGULATION CONTROL
15	HEMODIAGNOSTICA, LLC 345 FRESHFIELDS DR. JOHNS ISLAND, SC 29455 US 843-277-1642 / 843-277-1642	COAGULATION CONTROL PLASMA (LEVEL 1,2,3)	COAGULATION CONTROL PLASMA
16	HYPHEN BIOMED 155 RUE D' ERAGNY ZAC NEUVILLE-UNIVERSITE NEUVILLE SUR OISE, 95000 FR 33-1-34406510 / 33-1-34406510	BIOPHEN LOW MOLECULAR WEIGHT HEPARIN CONTROL/CONTROL LOW, UNFRACTIONATED CONTRO	PLASMA COAGULATION CONTROL
17	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE	PLASMA CONTROL
18	INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	DIRECT CHECK	WHOLE BLOOD CONTROL
19	INTERNATIONAL TECHNIDYNE CORPORATION 330 TALMADGE RD. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON DIRECT CHECK CONTROLS AND ABNORMAL CONTROLS	QUALITY CONTROL REAGENTS
20	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	HEMOCHRON DIRECT CHECK CONTROLS AND ABNORMAL CONTROLS	QUALITY CONTROL REAGENTS
21	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	COAGULATION CONTROL	COAGULATION CONTROL
22	MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. PARKER, CO 80134 US 763-514-4000 / 763-391-9030	MULTIPLE	COAGULATION CONTROL PLASMA
23	MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-391-9030	MULTIPLE	COAGULATION CONTROL PLASMA
24	PENTAPHARM LTD. ENGELGASSE 109 BASEL, BASEL-STADT, 4002 SZ 41-61-7064848 / 41-61-7064848	PEFAKIT APC-R FACTOR V LEIDEN CONTROLS	QUALITY CONTROL MATERIAL
25	PRECISION BIOLOGIC INC. 140 EILEEN STUBBS AVE DARTMOUTH, N.S., B3B 0A9 CA 902-468-6422 / 800-267-2796	CRYO-CHECK IN-VITRO COAGULATION CONTROL SYSTEM	CITRATED HUMAN PLASMA
26	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MAGIC B12 FOLATE 100 TESTS/BINDER/TRACER/DDT	B12 FOLATE TEST
27	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	VERIFY 1,2,3 VERIFY I, II, III, MDA VERIFY I, II, III, REFERENCE PLASMA	VERIFY 1,2,3 VERIFY I, II, III, MDA VERIFY I, II, III, REFERENCE PLASMAS
28	WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. CHATTANOOGA, TN 37416 US 423-296-0090 / 423-296-0090	HEPARIN 1	HEPARIN CONTROL PLASMA