Genentech Inc

FDA Filings

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

Genentech Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2917293
FEI Number2917293
NameGENENTECH, INC.
Owner & OperatorGenentech, Inc.
Contact Address1 DNA Way
South San Francisco CA 94080 US
Official Correspondent
  • Sujatha Narayan
  • 1-650-2388962-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1 DNA Way
South San Francisco, CA 94080 US



FDA Filings

Device
Company
DeviceDate
Genentech, Inc.
Prescription Medication2024-04-15
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2024-04-04
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2024-03-15
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2024-03-14
Genentech, Inc., Roche Diagnostics GmbH Pharma Biotech, Roche Singapore Technical Operations Pte. Ltd
Prescription Medication2024-03-02
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Genentech, Inc. (Hillsboro)
Prescription Medication2024-02-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, F. Hoffmann-La Roche AG, Roche Ireland Limited
Prescription Medication2024-02-24
Genentech, Inc., Chugai Pharma Manufacturing Co., Ltd. (Ukima), Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya), F. Hoffmann-La Roche Ltd. (KAU), Roche Diagnostics GmbH
Prescription Medication2024-02-24
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd. (RSTO), Roche Diagnostics GmbH, Genentech, Inc
Prescription Medication2024-02-22
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2024-02-08
Genentech, Inc., Genentech, Inc
Prescription Medication2024-02-03
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Singapore Technical Operation, Pte. Ltd. (RSTO), Roche Diagnostics GmbH
Prescription Medication2024-01-30
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2024-01-23
Genentech, Inc., F. Hoffmann-La Roche AG
Prescription Medication2024-01-12
Genentech, Inc., F. Hoffmann-La Roche Ltd
Prescription Medication2023-12-16
Genentech, Inc.
Prescription Medication2023-12-13
Genentech, Inc., Excella GmbH & Co. KG, F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG, F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
Prescription Medication2023-12-05
Genentech, Inc., F. Hoffmann-La Roche AG
Prescription Medication2023-12-01
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Genentech, Inc. (Hillsboro)
Prescription Medication2023-11-30
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2023-11-04
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2023-11-03
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2023-10-13
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2023-09-13
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2023-09-02
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Singapore Technical Operation, Pte. Ltd. (RSTO), Roche Diagnostics GmbH
Prescription Medication2023-08-30
Genentech, Inc., Roche Diagnostics GmbH Pharma Biotech, Roche Singapore Technical Operations Pte. Ltd
Prescription Medication2023-08-29
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2023-08-25
Genentech, Inc., Roche Diagnostics GmbH Pharma Biotech, Roche Singapore Technical Operations Pte. Ltd
Prescription Medication2023-08-25
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2023-08-24
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Genentech, Inc. (Hillsboro)
Prescription Medication2023-08-18
Genentech, Inc.
Prescription Medication2023-08-18
Genentech, Inc.
Prescription Medication2023-07-28
Genentech Inc., F. Hoffmann-La Roche Ltd., Charles River Laboratories, Inc.
Prescription Medication2023-07-14
Genentech, Inc.
Prescription Medication2023-07-13
Genentech, Inc., Chugai Pharma Manufacturing Co., Ltd. (Ukima), Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya), F. Hoffmann-La Roche Ltd. (KAU), Roche Diagnostics GmbH
Prescription Medication2023-07-13
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2023-06-28
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd.
Prescription Medication2023-06-22
Genentech, Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2023-06-13
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH
Prescription Medication2023-06-08
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2023-06-08
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG, Roche Singapore Technical Operation, Pte. Ltd. (RSTO)
Prescription Medication2023-05-23
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2023-04-29
Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Hillsboro), Roche Diagnostics GmbH, Genentech, Inc. (OCN), Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2023-04-13
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Singapore Technical Operation, Pte. Ltd. (RSTO), Roche Diagnostics GmbH
Prescription Medication2023-04-08
Genentech, Inc., F. Hoffmann-La Roche AG
Prescription Medication2023-04-06
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2023-04-04
Genentech, Inc., F. Hoffmann-La Roche Ltd
Prescription Medication2023-03-31
Genentech, Inc., Roche Diagnostics GmbH Pharma Biotech, Roche Singapore Technical Operations Pte. Ltd
Prescription Medication2023-03-31
Genentech, Inc., Chugai Pharma Manufacturing Co., Ltd. (Ukima), Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya), F. Hoffmann-La Roche Ltd. (KAU), Roche Diagnostics GmbH
Prescription Medication2023-03-28
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, F. Hoffmann-La Roche AG, Roche Ireland Limited
Prescription Medication2023-03-14
Genentech, Inc., F. Hoffmann-La Roche Ltd
Prescription Medication2023-03-09
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2023-02-07
GENENTECH INC
2023-01-01 03:37:21
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2023-01-01
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2022-12-30
Genentech Inc., F. Hoffmann-La Roche Ltd., Charles River Laboratories, Inc.
Prescription Medication2022-12-22
Genentech, Inc., Excella GmbH & Co. KG, F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG, F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
Prescription Medication2022-12-21
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG, Roche Singapore Technical Operation, Pte. Ltd. (RSTO)
Prescription Medication2022-12-20
Genentech, Inc., F. Hoffmann-La Roche Ltd
Prescription Medication2022-12-17
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd, Catalent Belgium SA, F. Hoffmann-La Roche AG
Prescription Medication2022-12-14
Genentech, Inc.
Prescription Medication2022-12-14
Genentech, Inc., Chugai Pharma Manufacturing Co., Ltd. (Ukima), Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya), F. Hoffmann-La Roche Ltd. (KAU), Roche Diagnostics GmbH
Prescription Medication2022-12-08
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, F. Hoffmann-La Roche AG, Roche Ireland Limited
Prescription Medication2022-12-06
Genentech, Inc., F. Hoffmann-La Roche AG
Prescription Medication2022-12-03
Genentech, Inc., Boehringer Ingelheim Pharma GmbH and Co. KG, Roche Singapore Technical Operations Pte. Ltd., Genentech, Roche Diagnostics GmbH, Patheon Manufacturing Services LLC, Bioreliance Corporation
Prescription Medication2022-12-02
Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Hillsboro), Roche Diagnostics GmbH, Genentech, Inc. (OCN), Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-12-02
Genentech, Inc., F. Hoffmann-La Roche Ltd, Genentech Inc., Roche Singapore Technical Operations Pte. Ltd. (RSTO), Roche Diagnostics GmbH, Genentech, Inc
Prescription Medication2022-12-02
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-12-01
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-11-23
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Sharp Corporation
Prescription Medication2022-11-22
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-11-19
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-11-19
Genentech, Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-11-10
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2022-10-27
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-10-05
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG, Roche Diagnostics GmbH
Prescription Medication2022-09-28
Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics
Prescription Medication2022-09-16
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, F. Hoffmann-La Roche AG, Roche Ireland Limited
Prescription Medication2022-08-26
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2022-08-20
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Singapore Technical Operation, Pte. Ltd. (RSTO), Roche Diagnostics GmbH
Prescription Medication2022-08-12
Genentech, Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-08-08
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2022-07-27
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2022-07-26
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, F. Hoffmann-La Roche AG, Roche Ireland Limited
Prescription Medication2022-06-26
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2022-06-18
Genentech, Inc., Chugai Pharma Manufacturing Co., Ltd. (Ukima), Chugai Pharma Manufacturing Co., Ltd. (Utsunomiya), F. Hoffmann-La Roche Ltd. (KAU), Roche Diagnostics GmbH
Prescription Medication2022-06-17
Genentech Inc., F. Hoffmann-La Roche AG, F. Hoffmann-La Roche Ltd.
Prescription Medication2022-06-08
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-06-01
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd. (RSTO), Roche Diagnostics GmbH, Genentech, Inc
Prescription Medication2022-05-14
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-05-05
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-05-03
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-04-30
Genentech Inc., F. Hoffmann-La Roche Ltd., Charles River Laboratories, Inc.
Prescription Medication2022-04-28
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd. (RSTO), Roche Diagnostics GmbH, Genentech, Inc
Prescription Medication2022-04-16
Genentech, Inc., F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche AG
Prescription Medication2022-03-26
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2022-03-23
Genentech Inc., F. Hoffmann-La Roche Ltd., Charles River Laboratories, Inc.
Prescription Medication2022-03-16
Genentech, Inc., F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, Roche Singapore Technical Operations Pte. Ltd.
Prescription Medication2022-03-05
Genentech, Inc., Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics GmbH
Prescription Medication2022-03-03
Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd
Prescription Medication2022-02-24
GENENTECH INC
2022-02-01 22:37:11
Genentech, Inc.
Susvimo 2021-12-07
Genentech, Inc.
Susvimo 2021-12-07
Genentech, Inc.
Susvimo 2021-12-07
Genentech, Inc.
Susvimo 2021-12-07
GENENTECH INC
2021-10-26 19:25:01
GENENTECH INC
2020-12-02 13:47:38
Genentech Inc.
Enspryng2020-08-14
GENENTECH INC
2020-08-11 22:10:32
Genentech Inc.
EVRYSDI2020-08-07
GENENTECH INC
2020-06-30 22:19:52
Genentech Inc.
Rozlytrek2019-08-15
Genentech Inc.
Rozlytrek2019-08-15
Genentech, Inc.
TECENTRIQ2019-03-08
Genentech, Inc.
Herceptin Hylecta2019-02-28
Genentech, Inc.
Actemra ACTPen2018-11-19
Genentech, Inc
Xofluza2018-10-24
Genentech, Inc
Xofluza2018-10-24
Genentech, Inc.
Xolair PFS2018-09-28
Genentech, Inc.
Xolair PFS2018-09-28
Genentech, Inc.
Sterile Water2018-05-05
Genentech, Inc.
Hemlibra2017-11-16
Genentech, Inc.
Hemlibra2017-11-16
Genentech, Inc.
Hemlibra2017-11-16
Genentech, Inc.
Hemlibra2017-11-16
Genentech, Inc.
Rituxan Hycela2017-06-22
Genentech, Inc.
Rituxan Hycela2017-06-22
Genentech, Inc.
2017-03-28
Genentech, Inc.
OCREVUS2017-03-28
Genentech, Inc.
Herceptin2017-02-10
Genentech, Inc.
ESBRIET2017-01-11
Genentech, Inc.
ESBRIET2017-01-11
Genentech, Inc.
TECENTRIQ2016-05-18
Genentech, Inc.
ALECENSA2015-12-11
Genentech, Inc.
Cotellic2015-11-10
Genentech, Inc.
Mircera2014-10-24
Genentech, Inc.
Mircera2014-10-24
Genentech, Inc.
Mircera2014-10-24
Genentech, Inc.
Mircera2014-10-24
Genentech, Inc.
Mircera2014-10-24
Genentech, Inc.
ESBRIET2014-10-15
Genentech, Inc.
Gazyva2013-11-01
Genentech, Inc.
Actemra2013-10-21
Genentech, Inc.
KADCYLA2013-02-22
Genentech, Inc.
KADCYLA2013-02-22
Genentech, Inc.
LUCENTIS2012-08-10
Genentech, Inc.
PERJETA2012-06-08
Genentech, Inc.
FUZEON2012-04-10
Genentech, Inc.
ERIVEDGE2012-01-30
Genentech, Inc.
Pegasys2011-11-01
Genentech, Inc.
ZELBORAF2011-08-17
Genentech, Inc.
Pegasys2011-03-29
Genentech, Inc.
Tamiflu2011-03-21
Genentech, Inc.
Xenical2010-12-17
Genentech Inc.
2010-01-08
Genentech, Inc.
ACTEMRA2010-01-08
Genentech, Inc.
ACTEMRA2010-01-08
Genentech, Inc.
ACTEMRA2010-01-08
Genentech, Inc.
2009-09-04
Genentech, Inc.
Valcyte2009-08-28
Genentech, Inc.
LUCENTIS2006-06-30
Genentech, Inc.
Boniva2006-01-06
Genentech, Inc.
TARCEVA2005-04-30
Genentech, Inc.
TARCEVA2005-04-30
Genentech, Inc.
TARCEVA2005-04-30
Genentech, Inc.
Boniva2005-03-24
Genentech, Inc.
Invirase2004-12-17
Genentech, Inc.
Avastin2004-02-26
Genentech, Inc.
Avastin2004-02-26
Genentech, Inc.
XOLAIR2003-06-20
Genentech, Inc.
Pegasys2002-10-16
Genentech, Inc.
Cathflo Activase2001-09-04
Genentech, Inc.
Valcyte2001-03-29
Genentech, Inc.
TNKase2000-06-02
Genentech, Inc.
Tamiflu1999-10-27
Genentech, Inc.
Tamiflu1999-10-27
Genentech, Inc.
Tamiflu1999-10-27
Genentech, Inc.
CellCept1998-10-01
Genentech, Inc.
Herceptin1998-09-25
Genentech, Inc.
Herceptin1998-09-25
Genentech, Inc.
CellCept1998-08-12
Genentech, Inc.
Xeloda1998-04-30
Genentech, Inc.
Xeloda1998-04-30
Genentech, Inc.
Rituxan1997-11-26
Genentech, Inc.
Rituxan1997-11-26
Genentech, Inc.
CellCept1997-06-19
Genentech, Inc.
1995-12-29
Genentech, Inc.
Nutropin AQ NuSpin 201995-12-29
Genentech, Inc.
Nutropin AQ NuSpin 51995-12-29
Genentech, Inc.
Nutropin AQ NuSpin 101995-12-29
Genentech, Inc.
Invirase1995-12-06
Genentech, Inc.
CellCept1995-05-03
Genentech, Inc.
EC-Naprosyn1994-10-14
Genentech, Inc.
Pulmozyme1993-12-30
Genentech, Inc.
1989-06-23
Genentech, Inc.
Cytovene IV1989-06-23
Genentech, Inc.
Activase1987-11-13
Genentech, Inc.
Activase1987-11-13
Genentech, Inc.
Klonopin1975-06-02
Genentech, Inc.
Klonopin1975-06-02
Genentech, Inc.
Klonopin1975-06-02
GENENTECH INC
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GENENTECH INC
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GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
0000-00-00 00:00:00
GENENTECH INC
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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092614452Singapore,Singapore -> Oakland, CaliforniaDISPOSAL MEDICAL MASK200 CTN
2020092614444Singapore,Singapore -> Oakland, CaliforniaDISPOSAL MEDICAL MASK75 CTN
202009259081Singapore,Singapore -> Oakland, CaliforniaDISPOSAL MEDICAL MASK75 CTN
202009259089Singapore,Singapore -> Oakland, CaliforniaDISPOSAL MEDICAL MASK200 CTN
2020092541930Tokyo ,Japan -> Oakland, CaliforniaPHARMACEUTICAL MATERIAL H.S.CODE:2835:22320 DRM
2020092250285Taipei,China (Taiwan) -> Oakland, CaliforniaPH BUFFER FOR LAB RESEARCH USE MOPS.NA 40DRUMS 5 PLASTIC PLTS 5PLTS HS CODE 2904.9940 PKG
2020091839302Tokyo ,Japan -> Oakland, CaliforniaPHARMACEUTICAL MATERIAL ASF104C10 MRA40 PAL
2020091715957Anvers,Belgium -> Seattle, WashingtonPSI-M ISOLATOR ISOLATOR PSI-M HS-CODE 8421.39 PROJECT 10A-19-110 PROJECT 10A-19-052 PO 400236420515 PCS

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