Bioreliance

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2024-11-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2024-10-30
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2024-09-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2024-09-13
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-06-08
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-04-15
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-03-05
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-03-02
VBI Vaccines (Delaware) Inc., BioReliance, SciVac Ltd, Envigo CRS (Israel) Limited, Hy-Labs, IMI TAMI Institute for Research and Development Ltd.
Other Medication2024-02-24
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2024-01-05
VBI Vaccines (Delaware) Inc., BioReliance, SciVac Ltd, Envigo CRS (Israel) Limited, Hy-Labs, IMI TAMI Institute for Research and Development Ltd.
Other Medication2023-09-29
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2023-05-05
Genzyme Corporation, Genzyme Ireland Limited
Prescription Medication2023-03-06
VBI Vaccines (Delaware) Inc., BioReliance, SciVac Ltd, Envigo CRS (Israel) Limited, Hy-Labs, IMI TAMI Institute for Research and Development Ltd.
Other Medication2023-01-01
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2023-01-01
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2022-11-12
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-06-30
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-06-01
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-03-05
VBI Vaccines (Delaware) Inc., BioReliance, SciVac Ltd, Envigo CRS (Israel) Limited, Hy-Labs, IMI TAMI Institute for Research and Development Ltd.
Other Medication2021-12-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2021-12-01
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2021-10-13
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2021-09-01
Genzyme Corporation, Genzyme Ireland Limited
Prescription Medication2021-06-08
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2021-03-17
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2021-02-23
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2021-02-12
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2020-12-19
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2020-11-17
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2020-07-01
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2020-06-16
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2020-06-10
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2020-04-18
Genzyme Corporation, Genzyme Ireland Limited
Prescription Medication2020-03-27
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2019-11-19
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2019-06-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2019-04-24
Regeneron Pharmaceuticals, Inc., WuXi Advanced Therapies Inc., WuXi AppTec, BioReliance, Nitto, Sharp Corporation, Regn Ireland DAC, Catalent Indiana, LLC
Prescription Medication2019-03-28
Genzyme Corporation, Genzyme Ireland Limited
Prescription Medication2018-11-08

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