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Devices
Device Recall STAIA PACK cTnI 2nd GenTroponin
Model / Serial
All Lot Codes
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Product Description
ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 || Assay, Cardiac Marker
Manufacturer
Tosoh Bioscience Inc
1 Event
Recall of Device Recall STAIA PACK cTnI 2nd GenTroponin
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Manufacturer
Tosoh Bioscience Inc
Manufacturer Address
Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
Manufacturer Parent Company (2017)
Tosoh Corp.
Source
USFDA
Language
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