Devices

Coaguchek

  • Model / Serial
    All lots.
  • Product Classification
    Hematology and Pathology Devices
  • 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].
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA

75 devices with a similar name

Learn more about the data here

COAGUCHEK XS PT TEST STRIPS I
  • Model / Serial
    11911822; 20646321; 20335921 || 23343322; 23194921; 23073621.
  • Product Description
    REAGENTS, CONTROLS AND CALIBRATORS USED IN DETERMINATIONS OF THE COAGULATION AREA APPARATUS OF SAMPLES OF HUMAN ORIGIN.
  • Manufacturer
    ROCHE DIAGNOSTICS GmBH || Importer: PRODUCTOS ROCHE S.A.
CoaguChek
Roche CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro Test Strips
  • Model / Serial
    Model: Models: 04625412019, 04800842190, 05530199190, 04625374190, 04625358019, 04625315019, Affected: All serial numbers
  • Manufacturer
    manufacturer #1479
Coaguchek XS meters
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
    Roche
Device Recall CoaguChek Pro DM System
70 more