Cobas

  • 모델명 / 제조번호(시리얼번호)
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • 제품 설명
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 918 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 50654, 50694, 50541, 50634, 50251, 50506, 50453, 50688, 50244, 50475, 50597, 50656, 50598, 50635, 50632, 50586, 50320, 50246, 50693, 50692, 50562, 50547, 50624, 50690, 50687, 50680, 50560, 50247, 50538, 50633, 50201, 50612, 50576, 50689, 50681, 50424, 50651, 50661, 50452, 50450, 50290, 50630, 50319, 50250, 50549, 50682, 50683, 50685, 50660, 50545, 50463, 50655, 50539, 50653, 50249, 50563, 50561, 50686, 50649, 50470, 50657, 50448, 50644, 50595, 50575, and 50679.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. || Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    63005401, 62893701, 62714901 and 21110900
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Diagnostics Corporation, Indianapolis, IN. || For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 05027012190, 05393850190, 05393850190, 05393868190 Lot #K11236, K15440, L00846, M05135, M11190, M12625, M14232, N00159, N02341, N05553, N05554, N07543, N08567
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom
  • 제품 설명
    COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; || COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 50865, 50626, 50798, 50731, 50654, 50541, 51023, 50946, 50989, 50634, 50506, 50251, 50887, 50948, 50453, 50688, 51111, 50997, 51122, 50244, 50790, 50475, 50597, 50740, 50656, 50793, 51086, 50999, 51146, 50635, 50744, 50586, 50632, 50846, 1167, 50693, 50787, 50670, 50672, 51128, 50941, 50562, 50788, 50547, 51003, 50624, 50677, 50678, 50814, 51015, 50687, 50680, 50894, 50560, 51004, 50247, 50538, 51118, 50926, 50847, 50841, 51127, 50741, 50764, 50633, 51106, 51116, 50201, 51124, 50612, 51088, 50576, 51016, 50689, 50681, 50424, 51126, 50959, 50878, 50784, 50661, 50761, 50452, 50450, 50290, 50947, 51327, 50630, 50985, 50763, 50319, 50984, 50250, 50549, 50925, 50844, 50660, 50845, 50683, 50735, 51056, 50463, 50775, 50840, 50734, 50655, 50843, 50758, 50852, 50539, 50651, 50653, 50657, 50964, 50563, 50742, 50738, 50727, 50934, 50561, 50803, 51000, 51107, 50686, 50815, 50649, 50470, 50759, 50644, 51053, 50739, 50595, 51087, 50575, and 50679.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including West Virginia and Texas.
  • 제품 설명
    Roche Cobas c 111 Analyzer || The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
하나 더 913 건 더