Microgenics Corporation

5 dispositifs dans la base de données

  • Modèle / numéro de série
    Part Number Lot number  OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S   All lots have an expiration date of 10/31/2015.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
  • Description du dispositif
    MAS Omni Immune PRO Controls
  • Modèle / numéro de série
    Part Number Lot number OIM-101 OIM15091 OIM-202 OIM15092 OIM-303 OIM15093 OIM-SP OIM1509S. All lots have an expiration date of 9/30/2015.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
  • Description du dispositif
    MAS Omni Immune Controls
  • Modèle / numéro de série
    Catalog Number: 10014432;  Lot Numbers:  1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
  • Description du dispositif
    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA || MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
  • Modèle / numéro de série
    MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014.  MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
  • Description du dispositif
    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; || Liquid Assayed Integrated Immunoassay Control. || Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. || .
  • Modèle / numéro de série
    Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013;  CAI-XL1, CXL13011, 31 JAN 2013;  CAI-XL2, CXL13012, 31 JAN 2013;  CAI-XL3, CXL13013, 31 JAN 2013;  CAI-XL4, CXL13014, 31 JAN 2013;  CAI-XLS, CXL1301S, 31 JAN 2013
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Worldwide, including Germany, France, Italy and Spain.
  • Description du dispositif
    ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. || Catalog Numbers & Description: || CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; || CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;

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  • Adresse du fabricant
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Société-mère du fabricant (2017)
  • Source
    USFDA
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