MULTIPLE MANUFACTURED BY REICHERT INC.

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Request for Information Form	Contact Information
Company Name	REICHERT INC.
Address	3362 WALDEN AVE.
City, State, Zip	DEPEW, NY 14043
Country	US
FDA Owner/Operator Phone	716-686-4500
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	MQM
FDA Classification Name	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1113
FDA Common Generic Name	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9055850
FDA Owner / Operator Name	REICHERT INC.
FDA Establishment Registration Number	1319721
FDA Registered Establishment Name	REICHERT INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-09-04
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	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	NBIL	NEONATAL BILIRUBIN
2	DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD. TELFORD, PA 18969 US 215-660-2078 / 215-660-2078	JM 103 JAUNDICE METER	JAUNDICE METER
3	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02421 US 781-861-4467 / 781-861-4467	SYNTHESIS	BILIRUBIN (TOTAL & UNBOUND) TEST SYSTEM
4	KONICA MINOLTA SENSING, INC. 3-91, DAISENNISHIMACHI SAKAI-KU SAKAI, OSAKA, 590-8551 JA 81-72-2413295 / 81-72-2413295	MULTIPLE	VARIOUS MODELS OF JAUNDICE METER SYSTEMS
5	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS MODELS OF BLOOD ANALYZERS
6	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US 724-387-4559 / 724-387-4559	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	BILIRUBIN ANALYZER