Medtest Holdings, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건

  • 모델명 / 제조번호(시리얼번호)
    Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Pointe Scientific Liquid Creatine Kinase Reagent Set || Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
  • 모델명 / 제조번호(시리얼번호)
    HEC200: " 616UE, Mfr. Date 2013-02, Exp. 2017-01 " 652UE, Mfr. Date 2013-07, Exp. 2017-07 " 720UE, Mfr. Date 2014-08, Exp. 2018-07 HNC200: " 858UN, Mfr. Date 2013-07, Exp. 2018-07 " 941 UN, Mfr. Date 2014-07, Exp. 2018-06
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) || HEC200 || " Sml amber glass vial with rubber stopper and black plastic screw cap. || " 1 0 control vials per box, 12 cell foam insert. || HNC200 || " Sml amber glass vials with rubber stopper and green plastic screw cap. || " 1 0 control vials per box, 12 cell foam insert. || Product Usage: || MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
  • 모델명 / 제조번호(시리얼번호)
    Model: H7575-57 Lot: 416703 Expiration date: 2016-01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    MI, MN, NJ, IL, NY. US Only.
  • 제품 설명
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
  • 모델명 / 제조번호(시리얼번호)
    Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    FL, AR, NICARAGUA, KOREA
  • 제품 설명
    The Pointe Scientific CK-MB Isoenzyme Control || Pointe Scientific CK-MB Level II Control, || C7562-12 Control Kit
  • 모델명 / 제조번호(시리얼번호)
    Model #'s C7568-CTL and C7568-STD  Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
  • 제품 설명
    Pointe Scientific CRP(HS) Wide Range Control Set and || Pointe Scientific CRP(HS) Wide Range Standard Set || 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
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