ACCURUN1 MULTI-MARKER NEGATIVE CONTROL MANUFACTURED BY BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN

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Request for Information Form	Contact Information
Company Name	BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN
Address	375 WEST ST.
City, State, Zip	WEST BRIDGEWATER, MA 02379
Country	US
FDA Owner/Operator Phone	508-580-1900
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	ACCURUN1 MULTI-MARKER NEGATIVE CONTROL
FDA Proprietary Device Name	ACCURUN1 MULTI-MARKER NEGATIVE CONTROL
FDA Owner / Operator Number	9041170
FDA Owner / Operator Name	SERACARE LIFE SCIENCES, INC
FDA Establishment Registration Number	1220394
FDA Registered Establishment Name	BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-27-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	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
2	BIOTEST AG LANDSTEINERSTR. 5 DREIEICH, D-63303 GM 49-610-38010 / 49-610-3801442	MULTIPLE	QUALITY CONTROL KIT FOR BLOOD BANKING REAGENTS
3	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	MULTIPLE	VARIOUS
4	IMMUCOR, INC. 3700 MANGUM RD., #451-M HOUSTON, TX 77092 US 770-441-2051 / 770-441-2051 5304	MULTIPLE	VARIOUS TYPES OF QC REAGENTS
5	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
6	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
7	ORTHO-CLINICAL DIAGNOSTICS, INC. ROUTE 202 RARITAN, NJ 08869 US 908-218-8177 / 908-218-8177	ORTHO CONFIDENCE SYSTEM	QC SYSTEM FOR BLOOD BANKING REAGENT