IMMULITE/IMMULITE 1000 LBP MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
Address	GLYN RHONWY
City, State, Zip	LLANBERIS, CAERNARFON,
Country	UK
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	NTM
FDA Classification Name	ANTIGEN, INFLAMMATORY RESPONSE MARKER, SEPSIS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3210
FDA Common Generic Name	IMMUNOASSAY FOR THE MEASUREMENT OF LBP
FDA Proprietary Device Name	IMMULITE/IMMULITE 1000 LBP
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	3002806944
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-04-05
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	BRAHMS AG NEUENDORFSTRASSE 25 HENNIGSDORF, 16761 GM 49-330-28830 / 410-897-9960	B.R.A.M.S. PCT LIA	PROCALCITONIN, PCT
2	CEZANNE S.A.S. 280, ALLEE GRAHAM BELL NIMES CEDEX 01, 30035 FR / 33-4-66365244	KRYPTOR	PCT KRYPTOR TEST SYSTEM
3	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE-IMMULITE 1000 LBP	IMMUNOASSAY FOR THE MEASUREMENT OF LBP