VITROS IMMUNODIAGNOSTIC PRODUCT NT-PROBNP REAGENT PACK MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS

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VITROS IMMUNODIAGNOSTIC PRODUCT NT-PROBNP REAGENT PACK

Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS
Address	FOREST FARM ESTATE WHITCHURCH
City, State, Zip	CARDIFF,
Country	UK
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	NBC
FDA Classification Name	TEST,NATRIURETIC PEPTIDE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1117
FDA Common Generic Name	NT-PROBNP TEST SYSTEM
FDA Proprietary Device Name	VITROS IMMUNODIAGNOSTIC PRODUCT NT-PROBNP REAGENT PACK
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	9680658
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	06-14-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ORTHO-CLINICAL DIAGNOSTICS

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 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	I-STAT BNP TEST	B-TYPE NATRIURETIC PEPTIDE
2	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	I-STAT BNP TEST	B-TYPE NATRIURETIC PEPTIDE
3	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	I-STAT BNP TEST	B-TYPE NATRIURETIC PEPTIDE
4	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000	ABBOT AXSYM(R),B-TYPE NATRIURETIC PEPTIDE(BNP),MICROPARTICLE ENZYME IMMUNOASSY	AXSYM (R) BNP MICROPARTICLE ENZYME IMMUNOASSAY
5	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423	TRIAGE R B-TYPE NATRIURETIC PEPTIDE BNP TEST	B-TYPE NATRIURETIC PEPTIDE TEST SYSTEM
6	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	DIMENSION PRO-BNP FLEX	DIMENSION PRO-BNP FLEX
7	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	ABBOTT ARCHITECT B-TYPE NATRIURETIC PEPTIDE	BNP TEST SYSTEM
8	NANOGEN POINT-OF-CARE (POC) DIAGNOSTICS DIVISION 135-2 THE WEST MALL TORONTO, ONTARIO, M9C 1C2 CA 416-621-3445 / 858-410-4683	STATUSFIRST CHF NT-PROBNP	STATUSFIRST CHF NT-PROBNP
9	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MULTIPLE	BNP ASSAY
10	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	BNP ASSAY