PACIFIC HEMOSTASIS THROMBOSCREEN MANUFACTURED BY FISHER DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	FISHER DIAGNOSTICS
Address	8365 VALLEY PIKE
City, State, Zip	MIDDLETOWN, VA 22645
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GIS
FDA Classification Name	TEST, FIBRINOGEN
FDA Device Classification Code	Standards
FDA Regulation Number	864.7340
FDA Common Generic Name	FIBRINOGEN ASSAY REAGENTS & KITS
FDA Proprietary Device Name	PACIFIC HEMOSTASIS THROMBOSCREEN
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	1181121
FDA Registered Establishment Name	FISHER DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-10-01
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	BIO/DATA CORP. 155 GIBRALTAR RD. HORSHAM, PA 19044 US 215-441-4000 / 215-441-4000	THROMBOKINETIC FIBRINOGEN ASSAY	FIBRINOGEN ASSAY
2	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	MULTIPLE	REAGENTS FOR FIBRINOGEN ASSAY
3	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	REAGENTS FOR FIBRINOGEN ASSAY
4	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE-IL TEST PT-FIBRINOGEN RECOMBINANT,IL TEST FIBRINOGEN HS ETC.	FIBRINOGEN DETERMINATION SYSTEM
5	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY FIBRINOGEN IMMUNOTURBIDIMETRIC ASSAY	FIBRINOGEN IMMUNOTURBIDIMETRIC ASSAY
6	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US 574-288-4377 / 574-288-4377	FIBRO TEK FIB	FIBRINOGEN KIT
7	ROWLEY BIOCHEMICAL INSTITUTE, INC. 10 ELECTRONICS AVE. DANVERS INDUSTRIAL PARK DANVERS, MA 01923 US 978-739-4883 / 978-739-4883	FIBRINOGEN TEST KIT	FIBRINOGEN TEST KIT
8	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	OWRENS BUFFER	TEST, FIBRINOGEN