Roche Diagnostics

FDA Filings

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

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

• ROCHE DIAGNOSTICS INTERNATIONAL LTD.
• Mike Leslie

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Activase Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics	Prescription Medication	2024-12-06
Ocrevus Zunovo Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd., Roche Singapore Technical Operations Pte. Ltd, Roche Diagnostics	Prescription Medication	2024-11-27
Ocrevus Zunovo Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd., Roche Singapore Technical Operations Pte. Ltd, Roche Diagnostics	Prescription Medication	2024-09-27
Tecentriq Hybreza Genentech, Inc., Roche Diagnostics GmbH, Roche Diagnostics, F. Hoffmann-La Roche Ltd.	Prescription Medication	2024-09-27
Ocrevus Zunovo Genentech, Inc., Roche Diagnostics GmbH, F. Hoffmann-La Roche Ltd., Roche Singapore Technical Operations Pte. Ltd, Roche Diagnostics	Prescription Medication	2024-09-21
PMN K221842 Roche Diagnostics	Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF	2022-12-07
PMN K220924 Roche Diagnostics	Elecsys HSV-2 IgG (08948887160)	2022-10-12
PMN K220923 Roche Diagnostics	Elecsys HSV-1 IgG (08948844160)	2022-10-12
PMN K220911 Roche Diagnostics	Elecsys CMV IgG	2022-10-12
PMN K220134 Roche Diagnostics	Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSH	2022-09-16
Activase Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics	Prescription Medication	2022-09-16
PMN K220176 Roche Diagnostics	Elecsys AFP	2022-09-15
PMN K203757 Roche Diagnostics	Elecsys AMH	2022-06-10
PMN K211685 Roche Diagnostics	Elecsys Testosterone II	2022-05-06
PMN K210546 Roche Diagnostics	Elecsys ProBNP II, Elecsys ProBNP II STAT	2022-03-31
PMA P190034S001 Roche Diagnostics	Elecsys Anti-HBs II	2021-12-16
Activase Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics	Prescription Medication	2021-12-01
PMA P190005S001 Roche Diagnostics	Elecsys Anti-HBe, PreciControl Anti-HBe	2021-11-01
PMN K201441 Roche Diagnostics	Elecsys Troponin T Gen 5	2021-09-21
PMN K210901 Roche Diagnostics	Elecsys Vitamin D Total III	2021-09-01
PMN K203227 ROCHE DIAGNOSTICS	Elecsys HCG STAT	2021-08-18
PMN K211302 Roche Diagnostics	Elecsys Syphilis	2021-07-20
PMA P190034 Roche Diagnostics	Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck	2021-02-23
PMA P190005 Roche Diagnostics	Elecsys Anti-HBe, PreciControl Anti-HBe	2021-02-03
Activase Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics	Prescription Medication	2020-12-08
PMN K200811 Roche Diagnostics	Cobas U 701 Microscopy Analyzer	2020-11-06
PMN K192815 Roche Diagnostics	Elecsys BRAHMS PCT	2020-03-09
PMN K193313 Roche Diagnostics	Elecsys Anti-TSHR	2020-02-27
PMN K191899 Roche Diagnostics	Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions	2019-08-16
PMN K190428 Roche Diagnostics	Elecsys Anti-HAV II	2019-08-13
PMN K183432 Roche Diagnostics	Cobas U 601 Urinalysis Test System	2019-05-07
PMN K190773 Roche Diagnostics	Elecsys TSH	2019-04-16
Activase Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics	Prescription Medication	2018-12-13
PMN K173857 Roche Diagnostics	Elecsys Tacrolimus	2018-11-06
PMN K181233 Roche Diagnostics	Elecsys FT4 III	2018-09-18
PMN K173927 Roche Diagnostics	Elecsys BRAHMS PCT	2018-07-06
PMN K181492 Roche Diagnostics	Elecsys CA 15-3 II	2018-06-22
PMN K180693 Roche Diagnostics	CoaguChek XS Pro System	2018-04-19
PMN K180684 Roche Diagnostics	CoaguChek XS Plus System	2018-04-19
PMN K171605 Roche Diagnostics	Elecsys CA 15-3 II	2018-02-20
PMN K170960 Roche Diagnostics	CoaguChek Vantus System	2017-12-25
PMN K162678 ROCHE DIAGNOSTICS	Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl	2017-06-23
PMN K162526 ROCHE DIAGNOSTICS	Creatine Kinase-MB	2017-05-26
PMN K170938 Roche Diagnostics	CalSet IGF-1	2017-04-26
PMN K170678 Roche Diagnostics	Beta-CrossLaps CalCheck 5	2017-04-04
PMN K163569 Roche Diagnostics	Elecsys CMV IgM	2017-03-17
PMN K162840 Roche Diagnostics	Elecsys Vitamin D Total II, Vitamin D Total II CalSet, PreciControl Vitamin D Total II, Vitamin D CalCheck 5	2017-02-08
PMN K162606 ROCHE DIAGNOSTICS	Elecsys TSH Assay, Cobas E 801 Immunoassay Analyzer	2017-01-23
PMN K162895 Roche Diagnostics	Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5	2017-01-18
PMN K162173 Roche Diagnostics	Elecsys CYFRA 21-1 CalCheck 5	2017-01-12
De Novo DEN150057 ROCHE DIAGNOSTICS	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	2016-12-19
PMN K160915 ROCHE DIAGNOSTICS	Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker	2016-12-14
PMN K160910 ROCHE DIAGNOSTICS	Elecsys Syphilis	2016-07-28
PMN K153607 ROCHE DIAGNOSTICS	ROMA Calculation Tool Using Elecsys Assays	2016-06-15
PMN K160729 Roche Diagnostics	Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5	2016-06-13
PMN K152227 ROCHE DIAGNOSTICS	Elecsys Cortisol II, Cortisol II CalSet	2016-04-27
PMN K153301 ROCHE DIAGNOSTICS	Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II	2016-04-08
PMN K152526 ROCHE DIAGNOSTICS	Elecsys Progesterone III CalSet	2015-10-02
PMN K151786 Roche Diagnostics	Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet	2015-09-24
PMN K150955 ROCHE DIAGNOSTICS	Elecsys Progesterone III Cal Check 5	2015-05-01
PMN K141867 Roche Diagnostics	ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM	2015-03-03
PMN K143342 Roche Diagnostics	Elecsys T-Uptake Calset	2014-12-19
PMN K143284 ROCHE DIAGNOSTICS	Elecsys Estradiol III Calcheck	2014-12-16
PMN K142133 Roche Diagnostics	ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM	2014-10-24
PMN K141426 Roche Diagnostics	ELECSYS FOLATE III	2014-10-17
PMN K142127 Roche Diagnostics	ELECSYS ESTRADIOL III CALCHECK 5	2014-09-05
PMN K133741 Roche Diagnostics	ACCU-CHEK Performa Blood Glucose Monitoring System	2014-08-29
PMN K142021 Roche Diagnostics	Elecsys Estradiol III CalSet	2014-08-12
PMN K141143 Roche Diagnostics	COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET	2014-07-17
PMN K140112 Roche Diagnostics	CA 125 II CALSET II	2014-06-06
PMN K140373 Roche Diagnostics	ISE INDIRECT NA, K, C1 FOR GEN 2	2014-05-22
PMN K140404 Roche Diagnostics	ELECSYS CK-MB STAT IMMUNOASSAY	2014-05-08
PMN K140534 Roche Diagnostics	ELECSYS PRECICONTROL TS	2014-03-27
PMN K131605 Roche Diagnostics	ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY	2014-02-28
PMN K131244 Roche Diagnostics	ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET	2014-01-27
PMN K132418 Roche Diagnostics	COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2	2013-12-18
PMN K132828 Roche Diagnostics	ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3	2013-12-04
PMN K133330 Roche Diagnostics	C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN	2013-11-26
PMN K133284 Roche Diagnostics	ELECSYS CK-MB CALCHECK 5	2013-11-22
PMN K132571 Roche Diagnostics	ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY	2013-10-18
PMN K131544 Roche Diagnostics	COBAS C BILIRUBIN TOTAL GEN.3	2013-07-17
PMN K123726 Roche Diagnostics	COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2	2013-05-21
PMN K123965 Roche Diagnostics	COBAS INTEGRA BILIRUBIN DIRECT GEN.2	2013-02-28
PMN K113614 Roche Diagnostics	ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	2013-02-12
PMN K122242 Roche Diagnostics	ELECSYS CA 15-3 II CALCHECK 5	2012-12-05
PMN K122722 Roche Diagnostics	COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160	2012-11-29
PMN K121679 Roche Diagnostics	ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM	2012-10-11
PMN K112624 Roche Diagnostics	ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5	2012-09-10
PMN K121895 Roche Diagnostics	ELECSYS HSV-2 IGG IMMUNOASSAY	2012-08-24

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• ROCHE PROFESSIONAL DIAGNOSTICS
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100031 Supplement NumberS027 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE DIAGNOSTICS, INC.
• Roche Diagnostics GmbH Pharma Biotech
• Genentech, Inc.
• Genentech, Inc. (SSF)
• Genentech, Inc. (Vacaville)
• Genentech, Inc. (Hillsboro)
• Hospira
• Genentech, Inc. (Oceanside)
• Roche Singapore Technical Operations Pte. Ltd.
• F. Hoffmann-La Roche Ltd.

Related Finance Registrations

NCAGE Code	SBX50	ROCHE DIAGNOSTICS
CAGE Code	SBX50	ROCHE DIAGNOSTICS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020073032032	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL
2020073030067	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL
2020073030264	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL
2020073031993	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PCS
2020073032520	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL
2020073030169	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PCS
2020073031169	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL
2020072436421	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASSAY TIP/CUP	54 PAL