bioMerieux Inc

5 devices in the database

  • Model / Serial
    Lot #P108X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
  • Product Description
    VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Model / Serial
    Lot #B28E
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines.
  • Product Description
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Model / Serial
    Software version R.02.00.17
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France.
  • Product Description
    OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
  • Model / Serial
    Lot #M83X, Exp. 4/15/05
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China.
  • Product Description
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Model / Serial
    Lot P61X, Exp. 5/12/05
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
  • Product Description
    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

23 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
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