Roche Diagnostics Corp.

116 devices in the database

  • Model / Serial
    Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].
  • Model / Serial
    Lots 175646 and 174558.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
  • Model / Serial
    All Lots with REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.
  • Product Description
    Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. || Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
  • Model / Serial
    All Lots with REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.
  • Product Description
    Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. || Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
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2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
  • Source
    USFDA
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA