VIDAS Lyme IgG and IgM (LYT) Assay

  • 모델명 / 제조번호(시리얼번호)
    Lot #777450001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made nationwide to hospitals and laboratories.
  • 제품 설명
    VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA