The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
관련기사 - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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모델명 / 제조번호(시리얼번호)
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제품 설명
Siemens Healthcare Diagnostics: Dimension Vista
- Manufacturer
- 1 Event
제조사
- 제조사 모회사 (2017)
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Source
MHRA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 594 건
데이터에 대해 더 자세히 알아보기 여기
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모델명 / 제조번호(시리얼번호)
Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
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제품 설명
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge || This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Lots 12135AE and 12171BB
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
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제품 설명
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) || The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
lot 3GM081, exp. 07-01-2014
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland
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제품 설명
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. || The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System.
- Manufacturer
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모델명 / 제조번호(시리얼번호)
catalog #K3105A, material #10470481, All in-date lots
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution: US (nationwide) and country of: Canada.
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제품 설명
Dimension Vista¿ HbA1c
- Manufacturer
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모델명 / 제조번호(시리얼번호)
Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020
- 의료기기 분류등급
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의료기기 등급
2
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이식된 장치?
No
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유통
Worldwide Distribution: US (nationwide) and internationally to: Canada.
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제품 설명
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
- Manufacturer