DIMTEK D-DIMERFIBROTEK FDP MANUFACTURED BY R2 DIAGNOSTICS, INC.

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DIMTEK D-DIMERFIBROTEK FDP

Request for Information Form	Contact Information
Company Name	R2 DIAGNOSTICS, INC.
Address	1801 COMMERCE DR.
City, State, Zip	SOUTH BEND, IN 46628
Country	US
FDA Owner/Operator Phone	574-288-4377
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GHH
FDA Classification Name	FIBRIN SPLIT PRODUCTS
FDA Device Classification Code	Standards
FDA Regulation Number	864.7320
FDA Common Generic Name	DIMTEK D-DIMERFIBROTEK FDP
FDA Proprietary Device Name	DIMTEK D-DIMERFIBROTEK FDP
FDA Owner / Operator Number	9026432
FDA Owner / Operator Name	R2 DIAGNOSTICS, INC.
FDA Establishment Registration Number	1835316
FDA Registered Establishment Name	R2 DIAGNOSTICS, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	05-15-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of R2 DIAGNOSTICS, 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	ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H MONMOUTH JUNCTION, NJ 08852 US 732-297-2222 / 732-297-2222 103	CARE START D-DIMER	D-DIMER TEST
2	AGEN BIOMEDICAL LTD. 7 & 11 DURBELL ST., ACACIA RIDGE BRISBANE, QUEENSLAND, 4110 AS 61-733-706300 / 61-733-706300	CLEARVIEW SIMPLIFY D-DIMER, SIMPLIFY D-DIMER	D-DIMER TEST
3	AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777	DIMERTEST (TM) D-DIMER TEST (VARIOUS)	FIBRIN DEGRADATION PRODUTS (FDP) TEST
4	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	MULTIPLE	D-DIMER LATEX AGGLUTINATION TEST
5	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423	TRIAGE, D-DIMER TEST	FLUORESCENCE IMMUNOASSAY FOR D-DIMER
6	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS FDP PRODUCTS
7	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	MULTIPLE	REAGENTS FOR D-DIMER ASSAY
8	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	REAGENTS FOR D-DIMER ASSAY
9	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	PACIFIC HEMOSTASIS THROMBOSCREEN D-DIMER ASSAY	FIBRIN DEGRADATION PRODUCTS (FDP) TEST
10	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	TINA-QUANT D-DIMER	D-DIMER TEST SYSTEM
11	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	MINUTEX D-DIMER LATEX TEST	MINUTEX D-DIMER LATEX TEST