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Preguntas frecuentes
Créditos
Manufacturers
Siemens Healthcare Diagnostics GmbH
Empresa matriz del fabricante (2017)
Siemens Ag
Representante del fabricante
ABDULREHMAN AL GOSAIBI GTB
Source
SFDA
6 Events
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6 dispositivos en la base de datos
Lot-to-Lot Variability When Using Dimension® Lipase (LIPL)
Modelo / Serial
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
Descripción del producto
Dimension clinical chemistry system
ADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CP
Modelo / Serial
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
Descripción del producto
IVDs
ADVIA Chemistry Systems Urea Nitrogen (UN)
Modelo / Serial
Catalog number: 03040257 Siemens Material Number: 10309051 Lot Number: 408143 Exp Date 28/06/2018 Lot Number: 418290 Exp Date 28/06/2018
Descripción del producto
Urea Nitrogen
Dimension Integrated Chemistry Systems…
Modelo / Serial
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
Descripción del producto
IVDs, In vitro diagnostic devices
ADVIA Centaur CKMB Calibrator Bias and Out of Range Results Using Master Curve Material (MCM)
Modelo / Serial
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
Descripción del producto
IVDs
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