DIMERTEST (TM) D-DIMER TEST (VARIOUS) MANUFACTURED BY AMERICAN DIAGNOSTICA, INC.

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DIMERTEST (TM) D-DIMER TEST (VARIOUS)

Request for Information Form	Contact Information
Company Name	AMERICAN DIAGNOSTICA, INC.
Address	500 WEST AVENUE
City, State, Zip	STAMFORD, CT 06902
Country	US
FDA Owner/Operator Phone	203-602-7777
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	FIBRIN DEGRADATION PRODUTS (FDP) TEST
FDA Proprietary Device Name	DIMERTEST (TM) D-DIMER TEST (VARIOUS)
FDA Owner / Operator Number	1220602
FDA Owner / Operator Name	AMERICAN DIAGNOSTICA, INC.
FDA Establishment Registration Number	1220602
FDA Registered Establishment Name	AMERICAN DIAGNOSTICA, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	12-14-94
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of AMERICAN DIAGNOSTICA, 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	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	MULTIPLE	D-DIMER LATEX AGGLUTINATION TEST
4	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
5	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS FDP PRODUCTS
6	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	MULTIPLE	REAGENTS FOR D-DIMER ASSAY
7	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	REAGENTS FOR D-DIMER ASSAY
8	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
9	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US 574-288-4377 / 574-288-4377	DIMTEK D-DIMERFIBROTEK FDP	DIMTEK D-DIMERFIBROTEK FDP
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