This page includes the latest FDA filings for Roche Diagnostic Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | 1999-05-03 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | 1999-02-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | 1999-02-10 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | 1998-12-15 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | 1998-12-15 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | 1998-12-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | 1998-12-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | 1998-12-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | 1998-12-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | 1998-12-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP-ER | 1998-11-18 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES | 1998-11-18 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP AND TESTSTIK CONTROLS | 1998-10-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | 1998-10-01 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA REAGENT CASSETTES | 1998-09-28 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE | 1998-08-26 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN | 1998-08-18 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE CRP T CONTROL N | 1998-08-18 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) | 1998-06-05 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) | 1998-05-28 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) | 1998-05-28 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | 1998-05-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL | 1998-04-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | 1997-12-18 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | 1997-11-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON | 1997-10-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION | 1997-10-01 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | 1997-08-12 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P | 1997-08-06 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) | 1997-06-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT | 1997-06-16 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | 1997-02-04 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS IBTEGRA REAGENT CASSETTES | 1997-01-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP 5 (MODIFICATION) | 1996-12-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL | 1996-11-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | 1996-10-31 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE | 1996-10-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP AMPHETAMINES | 1996-10-07 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE FRUCTOSAMINE REAGENT | 1996-09-27 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE IMMUNOCHEMISTRY SYSTEM | 1996-08-30 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | 1996-08-16 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | 1996-07-23 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | 1996-07-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP TDM CALIBRATION VERIFICATION TEST SET | 1996-06-26 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | 1996-06-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | 1996-06-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE REAGENT FOR GLUCOSE | 1996-02-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P | 1996-02-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA REAGENT CASSETTES | 1996-01-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE CONTROL SERUM P | 1995-12-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE CONTROL SERUM N | 1995-12-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL | 1995-12-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID | 1995-10-30 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE REAGENT FOR BUN | 1995-10-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS MICROS HEMATOLOGY ANALYZER | 1995-10-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE DRUG FREE URINE | 1995-09-20 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CONTROLS | 1995-09-20 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE CALIBRATOR SERUM | 1995-09-20 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR | 1995-09-15 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN | 1995-09-12 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES | 1995-09-08 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | 1995-07-31 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION | 1995-06-01 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE FREE T3 EIA | 1995-04-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | 1995-04-05 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS | 1995-03-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE-TDM ONLEIN(TM) CONTROLS | 1995-02-07 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE(R) CALIBRATORS | 1995-01-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONTRAK POSITIVE CONTROL | 1995-01-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE PROPOXPHENE | 1994-12-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CONTROLS | 1994-12-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC | 1994-12-02 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR | 1994-12-02 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE REAGENT | 1994-10-31 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE AMMONIA (VARIOUS) | 1994-10-04 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE TDM CALIBRATION VERIFICATION TEST SET | 1994-09-02 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE REAGENT FOR CREATININE | 1994-08-26 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) | 1994-08-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS | 1994-07-06 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP REAGENTS AND CALIBRATORS | 1994-06-13 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS | 1994-03-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS | 1994-03-11 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE | 1994-01-27 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT | 1994-01-25 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R) CORE FT4 EIA | 1994-01-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS (R) CORE T4 EIA | 1994-01-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK | 1994-01-03 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS | 1993-12-29 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R) CORE T3 EIA | 1993-12-03 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE TSH EIA | 1993-12-03 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE ABUSCREEN ONLINE FOR METHADONE | 1993-09-24 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE FSH EIA | 1993-09-21 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED | 1993-09-15 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF | 1993-08-30 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE LOW-CUTOFF CONTROLS | 1993-08-26 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE PROLACTIN EIA | 1993-08-19 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR | 1993-08-09 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R) CORE IGE TOTAL EIA | 1993-08-05 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CONTROL | 1993-08-03 |
ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE(R) CALIBRATORS | 1993-08-03 |