Device Recall RF Latex Reagent

  • Modèle / numéro de série
    Lot 21675
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
  • Description du dispositif
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) || RF Latex (1156-001, Control# 172224 expiry 2019-12-31) || RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) || Product Usage: || RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stanbio Laboratory, LP, 1261 N Main St, Boerne TX 78006-3014
  • Société-mère du fabricant (2017)
  • Source
    USFDA