Devices

BD PrepStain System

Model / Serial
GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. || PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
Manufacturer
Bd Diagnostic Systems Tripath
1 Event
- Recall of BD PrepStain System

Manufacturer

Bd Diagnostic Systems Tripath

Manufacturer Address
Bd Diagnostic Systems Tripath, 4025 Stirrup Creek Dr, Durham NC 27703-9398
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

One device with a similar name

Learn more about the data here

BD PrepStain Systems

Model / Serial
Product Description
In-vitro diagnostics
Manufacturer
Becton Dickinson

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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