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
Historias - 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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Modelo / Serial
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Descripción del producto
IVD: Antibiotic susceptibility analyser
- Manufacturer
- 1 Event
Fabricante
- Empresa matriz del fabricante (2017)
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Source
SATP
458 dispositivos con un nombre similar
Más información acerca de la data acá
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Modelo / Serial
All lot numbers
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
There was no U.S. distribution as the cards were for export only to Canada and Sweden.
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Descripción del producto
VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.
- Manufacturer
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Modelo / Serial
All lot numbers
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
There was no U.S. distribution as the cards were for export only to Canada and Sweden.
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Descripción del producto
VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.
- Manufacturer
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Modelo / Serial
VTK23119 to VTK 23745
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Worldwide Distribution-- USA (nationwide) and the countries of Austria, Australia, Belgium, Brazil, Canada, China, Colombia, Germany, France, India, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirate, and United Kingdom.
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Descripción del producto
VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.
- Manufacturer
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Modelo / Serial
VTK2XL2129 and VTK2XL3250
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Worldwide Distribution-- USA (nationwide) and the countries of Austria, Australia, Belgium, Brazil, Canada, China, Colombia, Germany, France, India, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirate, and United Kingdom.
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Descripción del producto
VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.
- Manufacturer
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Modelo / Serial
lot number: 540274420
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Distributed only in HI.
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Descripción del producto
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. || For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
- Manufacturer