Devices

Mainline Confirms Strep A

  • Model / Serial
    Cat. # 3030-20: Lots 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595. Cat. # 3030-40: Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
  • Product Description
    Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.
  • Manufacturer
    Mainline Technology, Inc.
  • 1 Event

Manufacturer

Mainline Technology, Inc.
  • Manufacturer Address
    Mainline Technology, Inc., 3985 Research Park Dr, Ann Arbor MI 48108-2282
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Mainline Confirms Strep A DOTS
  • Model / Serial
    Lots 92465, 92480, 92525, 92540, 92580, 92600, 92640, 92650, 92680, 92700, 92705, 92720, and 92721.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
  • Product Description
    Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040.
  • Manufacturer
    Mainline Technology, Inc.
Device Recall Mainline Confirms Strep A,
  • Model / Serial
    Lot No: 94300.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).
  • Manufacturer
    Mainline Technology, Inc.