Roche Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Roche Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
FDA Owner/Operator Registration













FDA Filings

Device
Company
DeviceDate
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2021-12-16
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg Confirmatory Test2021-12-09
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II Auto Confirm2020-10-19
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II2020-02-27
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2019-04-24
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II (100/200 tests)2018-11-06
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2018-06-13
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II2018-01-18
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II2017-12-29
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2017-12-20
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II2017-11-01
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2017-08-31
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II (100/200 tests) Immunoassay2017-06-23
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II2016-12-23

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