Vitros

  • 모델명 / 제조번호(시리얼번호)
    All Vitros ECi units currently on the market (software version 3.1 or lower).
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
  • 제품 설명
    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS¿ Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, and Venezuela
  • 제품 설명
    VITROS¿ Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK || VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
  • 제품 설명
    VITROS Chemistry Products COCM Reagent
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
  • 제품 설명
    VITROS CA 125 II Calibrators || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    1) VITROS 250 (Product Code 8132086; Model # 3332); 2) VITROS 350 (Product Code 6802153; Model # 3330); 3) Mixing Cup Arrays (Product Code 1631779; Model # n/a)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
  • 제품 설명
    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems || Product Usage: || Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.
  • Manufacturer
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