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Devices
Device Recall PrepStain Tecan USII
Model / Serial
Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Product Description
PrepStain Tecan US-II. || For use in the screening and detection of cervical cancer.
Manufacturer
Becton Dickinson & Co.
1 Event
Recall of Device Recall PrepStain Tecan USII
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Manufacturer
Becton Dickinson & Co.
Manufacturer Address
Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA
Language
English
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