IMMULITE 2000/IMMULITE 2000XPi

제조사

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  • 모델명 / 제조번호(시리얼번호)
    UDI 00630414985725/Catalog # L2KCM2(D): Kit lots D255, D256, D257, D258, D259, D260, D261, D262, D263, D264, D266; UDI 00630414961163/Catalog # L2KCM2: Kit lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.
  • 제품 설명
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK || For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: L2KPS2 (SMN#10380986), L2KPS6 (SMN #10380996) Batch Number: L2KPS2 Lot 408 L2KPS6 Lot 408
  • 제품 설명
    Diagnostic medical devices in vitro
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Siemens: IMMULITE 2000/IMMULITE 2000XPi PSA
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Reptile alert immulit 2000 _siemens
  • Manufacturer