TECHNICON AUTOGROUPER 16-C SYSTEM MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	511 BENEDICT AVENUE
City, State, Zip	TARRYTOWN, NY 10591
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSZ
FDA Classification Name	SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY
FDA Device Classification Code	Standards
FDA Regulation Number	864.9175
FDA Common Generic Name	16-CHANNEL BLOODTYPING SYSTEM
FDA Proprietary Device Name	TECHNICON AUTOGROUPER 16-C SYSTEM
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	2432235
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date
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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1	BIOTEST AG LANDSTEINERSTR. 5 DREIEICH, D-63303 GM 49-610-38010 / 49-610-3801442	MULTIPLE	AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
2	DIAGNOSTIC GRIFOLS, S.A. PASSEIG FLUVIAL, 24 PARETS DEL VALLES, BARCELONA, 08150 SP 34-935-710400 / 34-935-710215	ORTHO PROVUE	AUTOMATED BLOOD BANK INSTRUMENT
3	ELDON BIOLOGICALS A/S SANDTOFTEN 10 GENTOFTE, DK-2820 DA / 454-593-1111	ELDONCARD	ELDONCARD
4	IMMUCOR, INC. 3130 GATEWAY DR. P.O. BOX 5625 NORCROSS, GA 30091 US 770-441-2051 / 770-441-2051 5304	ABS2000	AUTOMATED BLOOD BANK INSRUMENT
5	MICRO TYPING SYSTEMS, INC. 1295 S.W. 29TH AVE. POMPANO BEACH, FL 33069 US 954-623-9500 / 908-218-8177	ORTHO PROVUE	ANALYZER
6	MISHIMA OLYMPUS CO., LTD. 454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 3-334-02111 / 484-896-5688	PK SYSTEMS	AUTOMATED BLOOD GROUPING ANALYZER