ORTHO CONFIDENCE SYSTEM MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	ROUTE 202
City, State, Zip	RARITAN, NJ 08869
Country	US
FDA Owner/Operator Phone	908-218-8177
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSF
FDA Classification Name	KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
FDA Device Classification Code	Standards
FDA Regulation Number	864.9650
FDA Common Generic Name	QC SYSTEM FOR BLOOD BANKING REAGENT
FDA Proprietary Device Name	ORTHO CONFIDENCE SYSTEM
FDA Owner / Operator Number	2250051
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	2250051
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-01-93
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN 375 WEST ST. WEST BRIDGEWATER, MA 02379 US 508-580-1900 / 508-580-1900 2175	ACCURUN1 MULTI-MARKER NEGATIVE CONTROL	ACCURUN1 MULTI-MARKER NEGATIVE CONTROL
2	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	QUALITY CONTROL KIT FOR BLOOD BANKING REAGENTS
3	BIOTEST AG LANDSTEINERSTR. 5 DREIEICH, D-63303 GM 49-610-38010 / 49-610-3801442	MULTIPLE	QUALITY CONTROL KIT FOR BLOOD BANKING REAGENTS
4	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	MULTIPLE	VARIOUS
5	IMMUCOR, INC. 3700 MANGUM RD., #451-M HOUSTON, TX 77092 US 770-441-2051 / 770-441-2051 5304	MULTIPLE	VARIOUS TYPES OF QC REAGENTS
6	IMMUCOR, INC. 3130 GATEWAY DR. P.O. BOX 5625 NORCROSS, GA 30091 US 770-441-2051 / 770-441-2051 5304	CORQC	DAILY QUALITY CONTROL SYSYEM FOR ROUTINE BLOOD BANK REAGENTS
7	MEDION DIAGNOSTICS AG BONNSTRASSE 9 DUEDINGEN, CH-3186 SZ 41-26-4928535 / 41-26-492 8535	BLOOD BANK QUALITY ASSURANCE II TESTING REAGENTS & CELLS	BBQA II