Device Recall Tecan Infinite 200.

  • 모델명 / 제조번호(시리얼번호)
    Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940; PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
  • 제품 설명
    Tecan Infinite 200. || The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • 제조사 모회사 (2017)
  • Source
    USFDA