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Devices
VITROS Immunodiagnostic Products Troponin I Reagent Pack
Model / Serial
Lots 3151 and 3170
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide-including USA, Canada, and Bermuda
Product Description
VITROS¿ Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
Manufacturer
Ortho-Clinical Diagnostics
1 Event
Recall of VITROS Immunodiagnostic Products Troponin I Reagent Pack
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Manufacturer
Ortho-Clinical Diagnostics
Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626-5101
Source
USFDA
Language
English
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