Manufacturers

Siemens Healthcare Diagnostics GmbH

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 6 건

Lot-to-Lot Variability When Using Dimension® Lipase (LIPL)
  • 모델명 / 제조번호(시리얼번호)
    Flex® reagent cartridge lots GD9002, GA9003, GB9032 and GA9038 ………………………………. FDA update codes: Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Lot Numbers: 18128BA, 18172BA, 18186BB
  • 제품 설명
    Dimension clinical chemistry system
ADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CP
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur aTG (100 test kit) : 10492398 Lots: 68748302 68749302 83577304 88637304 05610306 96436306 19097308 31866310 45386310 55627312 69208316 73000316 ADVIA Centaur aTG (500 test kit : 10492399 Lots: 68750302 68751302 83578304 91382304 04642306 08116306 19098308 22635308 33640310 39133310 55625312 55626312 56285312 69206316 73001316
  • 제품 설명
    IVDs
ADVIA Chemistry Systems Urea Nitrogen (UN)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 03040257 Siemens Material Number: 10309051 Lot Number: 408143 Exp Date 28/06/2018 Lot Number: 418290 Exp Date 28/06/2018
  • 제품 설명
    Urea Nitrogen
Dimension Integrated Chemistry Systems…
  • 모델명 / 제조번호(시리얼번호)
    Dimension® EXL 200 : 10636928 / Dimension® EXL with LM: 10472176 / Dimension® RxL Max: 10444828 / Dimension® RxL Max HM: 10444829 / Dimension® RxL Max HM STM: 10444831 / Dimension® Xpand® Plus: 10444837 / Dimension® Xpand® Plus HM: 10444838 / Dimension® Rx. This letter applies to Dimension systems listed in attachment running software version 10.2.2
  • 제품 설명
    IVDs, In vitro diagnostic devices
ADVIA Centaur CKMB Calibrator Bias and Out of Range Results Using Master Curve Material (MCM)
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur CKMB Calibrator : 09318028 : 10311570 Lot : 57834A64, 57835A64, 72519A64, 98115A64 ADVIA Centaur CKMB MCM : 07867768 : 10309782 Lot: 35061 ......................................... FDA update codes: ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211 Atellica IM CKMB Master Curve Material, Cat No. 10995534 SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210 Atellica IM CKMB Calibrator, Cat No. 10995532 SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
  • 제품 설명
    IVDs
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Siemens Healthcare Diagnostics GmbH
Siemens Healthcare Diagnostics GmbH
Siemens Healthcare Diagnostics GmbH
Siemens Healthcare Diagnostics GmbH
Siemens Healthcare Diagnostics GmbH
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