I-STAT PROTHROMBIN TIME TEST MANUFACTURED BY ABBOTT POINT OF CARE INC.

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I-STAT PROTHROMBIN TIME TEST

Request for Information Form	Contact Information
Company Name	ABBOTT POINT OF CARE INC.
Address	104 WINDSOR CENTER DR.
City, State, Zip	EAST WINDSOR, NJ 08520
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GJS
FDA Classification Name	TEST, TIME, PROTHROMBIN
FDA Device Classification Code	Standards
FDA Regulation Number	864.7750
FDA Common Generic Name	PROTHROMBIN TOME TEST
FDA Proprietary Device Name	I-STAT PROTHROMBIN TIME TEST
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2245578
FDA Registered Establishment Name	ABBOTT POINT OF CARE INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	09-17-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ABBOTT POINT OF CARE 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	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	I-STAT PROTHROMBIN TIME TEST	PROTHROMBIN TOME TEST
2	ABBOTT POINT OF CARE CANADA LIMITED 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	I-STAT PROTHROMBIN TIME TEST	PROTHROMBIN TIME TEST
3	AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777	ACTICLOT DPT	LA TEST
4	ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US 317-841-0458 / 317-841-0458	THROMBEX REAGENT	VARIOUS TYPE THROMBOPLASTIN
5	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	PROTHROMBIN TIME TEST
6	BIO/DATA CORP. 155 GIBRALTAR RD. HORSHAM, PA 19044 US 215-441-4000 / 215-441-4000	PLASTINEX, THROMBOPLASTIN, 15 X 10.0 ML	THROMBOPLASTIN REAGENT
7	BIOMEDICA DIAGNOSTICS INC. 94 WENTWORTH RD. WINSOR, NOVA SCOTIA, BON 2TO CA 902-798-5105 / 714-672-3553	QUIKCOAG, VITAL, TECCOAG, HEMODIAGNOSTICA	PROTHROMBIN TIME TEST
8	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	MULTIPLE	PROTHROMBIN TIME
9	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	MULTIPLE	REAGENTS FOR THE PROTHROMBIN TIME TEST
10	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	REAGENTS FOR THE PROTHROMBIN TIME TEST
11	DIAMED AG PRA ROND 23 CRESSIER SUR MORAT, CH 1785 SZ 412-667-45111x210 / 412-667-45111x210	MULTIPLE	THROMBOPLASTIN REAGENT FOR PT TEST
12	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	MULTIPLE	PROTHROMBIN TIME REAGENTS
13	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	MULTIPLE	PROTHROMBIN TIME TEST
14	HEMODIAGNOSTICA, LLC 345 FRESHFIELDS DR. JOHNS ISLAND, SC 29455 US 843-277-1642 / 843-277-1642	VARIOUS/MULTIPLE	PROTHROMBIN TIME (PT) TEST
15	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE	PROTHROMBIN TIME TESTS
16	INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON JR./FACTOR VI JR. MICROCOAGULATION PT TEST	MICROCOAGULATION PROTHROBIN TIME TEST
17	INTERNATIONAL TECHNIDYNE CORP. 6-8 OLSEN AVE. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	MULTIPLE	VARIOUS
18	INTERNATIONAL TECHNIDYNE CORPORATION 330 TALMADGE RD. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON JR. MICROCOAGULATION PT TEST CUVETTE	PT TEST CUVETTE
19	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	HEMOCHRON JR. MICROCOAGULATION PT TEST CUVETTE	PT TEST CUVETTE
20	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	PROTHROMBIN TIME	PROTHROMBIN TIME
21	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US 574-288-4377 / 574-288-4377	PHOSPHOPLASTIN-RL	PT-PROTHROMBIN TIME REAGENT
22	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	MDA SIMPLASTIN HTF,SIMPLASTIN HTF,SIMPLASTIN EXCEL, SIMPLASTIN EXCEL S, MDA SIM	PROTHROMBIN TIME (PT) TEST
23	WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. CHATTANOOGA, TN 37416 US 423-296-0090 / 423-296-0090	SERATHAN	PROTHROMBIN TIME TEST