Device Recall Variant II Turbo

  • Modèle / numéro de série
    Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.
  • Description du dispositif
    Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***" || Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
  • Description du dispositif
    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. || Calibrator/Diluent Set. || IVD. || Kit components: || Elution Buffer A, 2 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; || CD-ROM - || Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water || Whole Blood Primer, 6 x 1 mL || Sample Vials, 2 x 100 || Instruction Manual. || Bio-Rad Laboratories Inc. Hercules, CA 94547 || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
  • Manufacturer
  • Modèle / numéro de série
    All units of these models.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.
  • Description du dispositif
    VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. || Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 70200185.   Lot Nos.: 70200185, AA00190
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Italy.
  • Description du dispositif
    Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
  • Manufacturer