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Devices
Device Recall Creatinine Plus
Model / Serial
Catalog Numbers: 11775685216; 11875566216; 11875582216.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Creatinine Plus. || Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall Creatinine Plus
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Manufacturer
Roche Diagnostics Operations, Inc.
Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Language
English
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