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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CM-1000 Clinical Chemistry Analyzer; Getein 1100 Immunofluorescence Quantitative Analyzer; Getein 1160 Immunofluorescence Quantitative Analyzer; Getein 1180 Immunofluorescence Quantitative Analyzer; Getein 1200 Immunofluorescence Quantitative Analyzer; Getein 1600 Immunofluorescence Quantitative Analyzer; Getein 208 Hand-held Integrated System; MAGICL 6000 Chemiluminescence Immunoassay Analyzer; MAGICL 6000i Chemiluminescence Immunoassay Analyzer; MAGICL 6200 Chemiluminescence Immunoassay Analyzer; MAGICL 6800 Chemiluminescence Immunoassay Analyzer; MAGICL 8500 Chemiluminescence Immunoassay Analyzer
Classification Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product Code: JJE
Device Class: 1
Regulation Number: 862.2160
Medical Specialty: Clinical Chemistry
Registered Establishment Name: GETEIN BIOTECH, INC.
Registered Establishment Number: 3009984016
Owner/Operator: Getein Biotech, Inc.
Owner/Operator Number: 10064252
Establishment Operations: Manufacturer
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