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:

FDA Registration(s)
FDA Owner/Operator Registration













FDA Filings

Device
Company
DeviceDate
Roche Diagnostics
Cobas U 701 Microscopy Analyzer2020-11-06
Roche Diagnostics
Elecsys BRAHMS PCT2020-03-09
Roche Diagnostics
Elecsys Anti-TSHR2020-02-27
Roche Diagnostics
Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions2019-08-16
Roche Diagnostics
Elecsys Anti-HAV II2019-08-13
Roche Diagnostics
Cobas U 601 Urinalysis Test System2019-05-07
Roche Diagnostics
Elecsys TSH2019-04-16
Genentech, Inc., Genentech, Inc. (SSF), Genentech, Inc. (Vacaville), Genentech, Inc. (Hillsboro), Hospira, Genentech, Inc. (Oceanside), Roche Singapore Technical Operations Pte. Ltd., Roche Diagnostics
Prescription Medication2018-12-13
Roche Diagnostics
Elecsys Tacrolimus2018-11-06
Roche Diagnostics
Elecsys FT4 III2018-09-18
Roche Diagnostics
Elecsys BRAHMS PCT2018-07-06
Roche Diagnostics
Elecsys CA 15-3 II2018-06-22
Roche Diagnostics
CoaguChek XS Pro System2018-04-19
Roche Diagnostics
CoaguChek XS Plus System2018-04-19
Roche Diagnostics
Elecsys CA 15-3 II2018-02-20
Roche Diagnostics
CoaguChek Vantus System2017-12-25
ROCHE DIAGNOSTICS
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23
ROCHE DIAGNOSTICS
Creatine Kinase-MB2017-05-26
Roche Diagnostics
CalSet IGF-12017-04-26
Roche Diagnostics
Beta-CrossLaps CalCheck 52017-04-04
Roche Diagnostics
Elecsys CMV IgM2017-03-17
Roche Diagnostics
Elecsys Vitamin D Total II, Vitamin D Total II CalSet, PreciControl Vitamin D Total II, Vitamin D CalCheck 52017-02-08
ROCHE DIAGNOSTICS
Elecsys TSH Assay, Cobas E 801 Immunoassay Analyzer2017-01-23
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 52017-01-18
Roche Diagnostics
Elecsys CYFRA 21-1 CalCheck 52017-01-12
ROCHE DIAGNOSTICS
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 52016-12-19
ROCHE DIAGNOSTICS
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker2016-12-14
ROCHE DIAGNOSTICS
Elecsys Syphilis2016-07-28
ROCHE DIAGNOSTICS
ROMA Calculation Tool Using Elecsys Assays2016-06-15
Roche Diagnostics
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 52016-06-13
ROCHE DIAGNOSTICS
Elecsys Cortisol II, Cortisol II CalSet2016-04-27
ROCHE DIAGNOSTICS
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II2016-04-08
ROCHE DIAGNOSTICS
Elecsys Progesterone III CalSet2015-10-02
Roche Diagnostics
Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet2015-09-24
ROCHE DIAGNOSTICS
Elecsys Progesterone III Cal Check 52015-05-01
Roche Diagnostics
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM2015-03-03
Roche Diagnostics
Elecsys T-Uptake Calset2014-12-19
ROCHE DIAGNOSTICS
Elecsys Estradiol III Calcheck2014-12-16
Roche Diagnostics
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM2014-10-24
Roche Diagnostics
ELECSYS FOLATE III2014-10-17
Roche Diagnostics
ELECSYS ESTRADIOL III CALCHECK 52014-09-05
Roche Diagnostics
ACCU-CHEK Performa Blood Glucose Monitoring System2014-08-29
Roche Diagnostics
Elecsys Estradiol III CalSet2014-08-12
Roche Diagnostics
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET2014-07-17
Roche Diagnostics
CA 125 II CALSET II2014-06-06
Roche Diagnostics
ISE INDIRECT NA, K, C1 FOR GEN 22014-05-22
Roche Diagnostics
ELECSYS CK-MB STAT IMMUNOASSAY2014-05-08
Roche Diagnostics
ELECSYS PRECICONTROL TS2014-03-27
Roche Diagnostics
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY2014-02-28
Roche Diagnostics
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET2014-01-27
Roche Diagnostics
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 22013-12-18
Roche Diagnostics
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 32013-12-04
Roche Diagnostics
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN2013-11-26
Roche Diagnostics
ELECSYS CK-MB CALCHECK 52013-11-22
Roche Diagnostics
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
Roche Diagnostics
COBAS C BILIRUBIN TOTAL GEN.32013-07-17
Roche Diagnostics
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 22013-05-21
Roche Diagnostics
COBAS INTEGRA BILIRUBIN DIRECT GEN.22013-02-28
Roche Diagnostics
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2013-02-12
Roche Diagnostics
ELECSYS CA 15-3 II CALCHECK 52012-12-05
Roche Diagnostics
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 058526411602012-11-29
Roche Diagnostics
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM2012-10-11
Roche Diagnostics
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 52012-09-10
Roche Diagnostics
ELECSYS HSV-2 IGG IMMUNOASSAY2012-08-24
Roche Diagnostics
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV2012-07-25
Roche Diagnostics
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 52012-07-24
Roche Diagnostics
ACCU-CHECK COMBO SYSTEM2012-07-17
Roche Diagnostics
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B2012-05-14
Roche Diagnostics
ELECSYS LH CALCHECK 52012-05-10
Roche Diagnostics
CALCIUM GEN. 22012-05-08
Roche Diagnostics
GLUCOSE TEST SYSTEM2012-01-06
Roche Diagnostics
ROCHE ACETAMINOPHEN ASSAY2011-12-23
Roche Diagnostics
TINA-QUANT HBA1C GEN.22011-12-23
Roche Diagnostics
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM2011-09-21
Roche Diagnostics
ELECSYS MYOGLOBIN CALCHECK 52011-09-14

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020073032032Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073030067Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073030264Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073031993Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PCS
2020073032520Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073030169Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PCS
2020073031169Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020072436421Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL

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