Horiba Instruments, Inc dba Horiba Medical

17 devices in the database

  • Model / Serial
    DATE - MVT 25.08.2017
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
  • Model / Serial
    DATE - MVT 25.08.2017
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 || Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
  • Model / Serial
    All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.
  • Product Description
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 || The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 || The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
12 more