ApprovalTrail

Company · Mannheim, Germany

Roche Diagnostics Gmbh

Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.

Drug products (DIN)
0
0 authorized now
Natural health products
0
0 active licences
Medical device licences
573
383 active
Notices of Compliance
0

Medical device licences

Active licences first, newest first.

NameLicenceStatus
ELECSYS ANTI-SARS-COV-2116107Issued (active) · Class 2
ELECSYS PLGF114448Issued (active) · Class 3
ELECSYS SFLT-1116090Issued (active) · Class 3
ELECSYS TROPONIN T HS116035Issued (active) · Class 3
COBAS CLICK SYSTEM115560Issued (active) · Class 3
COBAS MICROBIAL INACTIVATION SOLUTION115466Issued (active) · Class 4
ELECSYS NFL115253Issued (active) · Class 2
ASLO2 TINA-QUANT ANTISTREPTOLYSIN-O II115162Issued (active) · Class 2
ELECSYS HBEAG QUANT114610Issued (active) · Class 4
IONIFY ANTIBIOTICS 2114607Issued (active) · Class 2
VENTANA SP 400114383Issued (active) · Class 2
IONIFY ANTIEPILEPTICS 1114147Issued (active) · Class 2
IONIFY ANTIBIOTICS 1114134Issued (active) · Class 2
IONIFY ANTIEPILEPTICS 2114021Issued (active) · Class 2
IONIFY STEROIDS 2113524Issued (active) · Class 2
VENTANA KAPPA AND LAMBDA DUAL ISH MRNA PROBE COCKTAIL113317Issued (active) · Class 2
ELECSYS PRO-C3113222Issued (active) · Class 2
IONIFY VITAMIN D 25 AND 24,25113065Issued (active) · Class 2
ELECSYS EBV IGM113041Issued (active) · Class 3
ELECSYS EBV VCA IGG113042Issued (active) · Class 3
ELECSYS EBV EBNA IGG113043Issued (active) · Class 3
VENTANA EBER PROBE112947Issued (active) · Class 2
ROCHE CARDIAC POC NT-PROBNP112752Issued with conditions · Class 3
SERUM DAT CONTROL SET112746Issued (active) · Class 2
COBAS I 601 ANALYTICAL UNIT112681Issued (active) · Class 2
IONIFY STEROIDS 1112678Issued (active) · Class 2
ELECSYS HCV DUO (DONOR SCREENING)112209Issued (active) · Class 4
ELECSYS AMH PLUS111506Issued (active) · Class 3
COBAS C 703111469Issued (active) · Class 3
CINTEC PLUS KIT111298Issued (active) · Class 2
COBAS PULSE SYSTEM111241Issued (active) · Class 3
CINTEC HISTOLOGY KIT111130Issued (active) · Class 2
ELECSYS ANTI-HEV IGM111054Issued (active) · Class 2
ELECSYS ANTI-HEV IGG111050Issued (active) · Class 2
ONLINE TDM METHOTREXATE110857Issued (active) · Class 2
PRECICONTROL HCC V2109520Issued (active) · Class 3
UPATH HER2 (4B5) IMAGE ANALYSIS FOR BREAST ALGORITHM109330Issued (active) · Class 3
ELECSYS CORTISOL III URINE109258Issued (active) · Class 2
ELECSYS BETA- AMYLOID (1-42) CSF II109183Issued (active) · Class 3
ELECSYS PHOSPHO-TAU (181P) CSF109184Issued (active) · Class 3
ELECSYS TOTAL-TAU CSF109186Issued (active) · Class 3
UPATH HER2 DUAL ISH IMAGE ANALYSIS FOR BREAST ALGORITHM108827Issued (active) · Class 3
UPATH PD-L1 (SP263) IMAGE ANALYSIS FOR NSCLC ALGORITHM108828Issued (active) · Class 3
VENTANA DP 600 SLIDE SCANNER108621Issued (active) · Class 2
ELECSYS TROPONIN T HS108451Issued (active) · Class 3
ELECSYS PROBNP II108453Issued (active) · Class 3
ELECSYS FT4 IV107788Issued (active) · Class 2
PRECICONTROL MATERNAL CARE107783Issued (active) · Class 3
STFR2 (TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR II)107739Issued (active) · Class 2
ELECSYS BRAHMS PCT107057Issued (active) · Class 2
ELECSYS ANDROSTENEDIONE107024Issued (active) · Class 2
ELECSYS VITAMIN D TOTAL III106383Issued (active) · Class 2
COBAS E 402 ANALYTICAL UNIT106230Issued (active) · Class 4
COBAS C 303 ANALYTICAL UNIT106203Issued (active) · Class 3
CRP4 TINA-QUANT C-REACTIVE PROTEIN IV104424Issued (active) · Class 2
ALANINE AMINOTRANSFERASE ACC. TO IFCC II104202Issued (active) · Class 2
ASPARTATE AMINOTRANSFERASE ACC. TO IFCC II104166Issued (active) · Class 2
ELECSYS GDF-15104019Issued (active) · Class 3
ELECSYS CHAGAS (DONOR SCREENING)104031Issued (active) · Class 4
ONLINE DAT METHAQUALONE104047Issued (active) · Class 2
COAGUCHEK PRO II103857Issued (active) · Class 3
THC2 ONLINE DAT CANNABINOIDS II103759Issued (active) · Class 2
ANTI-HAV II103739Issued (active) · Class 2
MDN2 ONLINE DAT METHADONE II103658Issued (active) · Class 2
BARB ONLINE DAT BARBITURATES PLUS103624Issued (active) · Class 2
AMIK2103554Issued (active) · Class 2
ANTI-TSHR103458Issued (active) · Class 2
PT OWREN103431Issued (active) · Class 3
VENTANA ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY103118Issued (active) · Class 3
APTT103027Issued (active) · Class 3
APTT SCREEN103028Issued (active) · Class 3
APTT LUPUS103029Issued (active) · Class 3
PT REC103030Issued (active) · Class 3
VENTANA ROS1 (SP384) RABBIT MONOCLONAL PRIMARY ANTIBODY103014Issued (active) · Class 2
AMMONIA II102998Issued (active) · Class 2
B2-MICROGLOBULIN102760Issued (active) · Class 2
TINA-QUANT ALBUMIN GEN.2102711Issued (active) · Class 2
ELECSYS PAPP-A102553Issued (active) · Class 3
ELECSYS FREE BETA HCG102552Issued (active) · Class 3
VENTANA CLDN18 (43-14A) ASSAY102424Issued (active) · Class 2
CONTROLS FOR COBAS T SYSTEMS102362Issued (active) · Class 3
COBAS T 511/T711 SYSTEM102370Issued (active) · Class 3
D-DI2102377Issued (active) · Class 2
TT (THROMBIN TIME)102378Issued (active) · Class 2
AT (ANTITHROMBIN)102379Issued (active) · Class 2
HIL TEST102381Issued (active) · Class 2
CC 25MM (CALCIUM CHLORIDE 25 MM)102319Issued (active) · Class 2
FIBRINOGEN102320Issued (active) · Class 2
ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION102259Issued (active) · Class 2
ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION102260Issued (active) · Class 2
START (ANTIGEN EXPRESS REAGENT)102246Issued (active) · Class 2
VENTANA PAN-TRK (EPR17341) ASSAY102167Issued (active) · Class 2
ELECSYS IGFBP-3102168Issued (active) · Class 2
VENTANA MMR IHC PANEL102133Issued (active) · Class 3
ELECSYS HIV DUO DONOR SCREENING102118Issued (active) · Class 4
COBAS C 503102105Issued (active) · Class 3
COAGUCHEK INRANGE SYSTEM101763Issued (active) · Class 3
ELECSYS IGF-1101067Issued (active) · Class 2
VENTANA DLL3 (SP347) ASSAY101000Issued (active) · Class 2
COBAS HBV100942Issued (active) · Class 3
ELECSYS ACTIVE B12100817Issued (active) · Class 2
COBAS HCV100782Issued (active) · Class 4
HDL-CHOLESTEROL GEN.4100647Issued (active) · Class 2
COBAS OMNI UTILITY CHANNEL100601Issued (active) · Class 2
COBAS M511 SYSTEM100164Issued (active) · Class 2
COBAS HIV-1100047Issued (active) · Class 3
COBAS HCV GT99577Issued (active) · Class 3
BATTERIES99252Issued (active) · Class 2
ELECSYS ANTI-HBC II (DONOR SCREENING AND BLOOD SCREENING)98928Issued (active) · Class 4
COBAS DPX98824Issued (active) · Class 3
MYOGLOBIN98819Issued (active) · Class 3
CK-MB98664Issued (active) · Class 3
PRECICONTROL LUNG CANCER98676Issued (active) · Class 3
INFORM EBER (EPSTEIN-BARR VIRUS EARLY RNA) PROBE98655Issued (active) · Class 2
AMH PLUS98550Issued (active) · Class 3
COBAS EGFR MUTATION TEST V298447Issued (active) · Class 3
ELECSYS DIGITOXIN98441Issued (active) · Class 2
ELECSYS TROPONIN T98353Issued (active) · Class 3
ELECSYS DIGOXIN98364Issued (active) · Class 2
ELECSYS PROBNP II98340Issued (active) · Class 3
ROCHE CARDIAC POC TROPONIN T98349Issued (active) · Class 3
COBAS HBV98314Issued (active) · Class 3
CREATINE KINASE-MB (CKMB)98300Issued (active) · Class 3
COBAS HIV-198110Issued (active) · Class 3
COBAS CMV98018Issued (active) · Class 3
VANC3 ONLINE TDM VANCOMYCIN GEN.397983Issued (active) · Class 2
ELECSYS FOLATE97835Issued (active) · Class 2
ELECSYS ANTI-HBS II97730Issued (active) · Class 4
SIROLIMUS97726Issued (active) · Class 3
HTLV I/II (DONOR SCREENING FOR TRANSPLANTATION AND BLOOD SCREENING)97727Issued (active) · Class 4
EVEROLIMUS TEST KIT97684Issued (active) · Class 3
COBAS E 80197374Issued (active) · Class 4
COBAS HCV97288Issued (active) · Class 4
COBAS MPX97223Issued (active) · Class 4
CREATINE KINASE (CK)97212Issued (active) · Class 2
SCC97113Issued (active) · Class 3
CARB4 ONLINE TDM CARBAMAZEPINE GEN.497009Issued (active) · Class 2
CINTEC PLUS CYTOLOGY KIT96955Issued (active) · Class 2
ACCU-CHEK INFORM II SYSTEM96800Issued (active) · Class 3
HANDHELD BASE UNIT96755Issued (active) · Class 2
COBAS WNV (DONOR SCREENING AND CADAVERIC TESTING)96393Issued (active) · Class 4
GLUC HEMOLYZING REAGENT GEN.296248Issued (active) · Class 2
GEN 2 HEMOLYZING REAGENTS96109Issued (active) · Class 2
COBAS C 513 ANALYZER SYSTEM96090Issued (active) · Class 2
PROGESTERONE96002Issued (active) · Class 2
SYPHILIS (DONOR SCREENING FOR TRANSPLANTATION AND BLOOD SCREENING)95943Issued (active) · Class 4
LDLC3 (LDL-CHOLESTEROL GEN3)95883Issued (active) · Class 2
COBAS B 101 SYSTEM95868Issued (active) · Class 3
ACET295574Issued (active) · Class 2
VITAMIN B12 II95221Issued (active) · Class 2
CORTISOL IMMUNOASSAY94989Issued (active) · Class 2
ESTRADIOL III94581Issued (active) · Class 2
FFPET RNA ISOLATION KIT94495Issued (active) · Class 3
CYCLOSPORINE93746Issued (active) · Class 3
TACROLIMUS93747Issued (active) · Class 3
AMH93692Issued (active) · Class 2
COBAS U 701 MICROSCOPY ANALYZER93681Issued (active) · Class 2
COBAS 6500 U601 URINALYSIS SYSTEM92684Issued (active) · Class 2
NAT SPECIMEN PREPARATION REAGENTS92631Issued (active) · Class 3
TINA-QUANT LIPOPROTEIN (A) GEN 291490Issued (active) · Class 2
TG II ASSAY91455Issued (active) · Class 2
BILIRUBIN TOTAL GEN.391420Issued (active) · Class 2
ELECSYS CALCITONIN91356Issued (active) · Class 3
TOXO IGG AVIDITY90889Issued (active) · Class 3
HCYS HOMOCYSTEINE90590Issued (active) · Class 2
FT4 (FREE THYROXINE)90484Issued (active) · Class 2
FT3 III (FREE TRIIODOTHYRONINE III)90485Issued (active) · Class 2
ELECSYS HIV COMBI PT (DONOR SCREENING)90336Issued (active) · Class 4
GENTAMICIN TEST KIT89543Issued (active) · Class 2
FOLATE RBC CALSET88687Issued (active) · Class 2
FOLATE RBC88688Issued (active) · Class 2
CMV IGG AVIDITY88527Issued (active) · Class 3
ELECSYS HE488384Issued (active) · Class 3
HSV-2 IGG88346Issued (active) · Class 3
MAGNESIUM TEST88226Issued (active) · Class 2
PRECICONTROL HSV87771Issued (active) · Class 3
COC2 COCAINE II ASSAY - REAGENTS87805Issued (active) · Class 2
BARB BARBITURATES PLUS ASSAY - REAGENTS87807Issued (active) · Class 2
HER2 DUAL ISH DNA PROBE COCKTAIL87564Issued (active) · Class 3
DILUENT HEPATITIS A87392Issued (active) · Class 2
LIGHTCYCLER 2.0 SOFTWARE87100Issued (active) · Class 3
PHENCYCLIDINE PLUS87034Issued (active) · Class 2
OPIATES87035Issued (active) · Class 2
VENTANA ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY87036Issued (active) · Class 3
HSV-1 IGG87037Issued (active) · Class 2
HBSAG II QUANT (HEPATITIS B SURFACE ANTIGEN QUANTITATIVE DETERMINATION)86962Issued (active) · Class 3
QUINIDINE FOR ROCHE/HITACHI AND COBAS C SYSTEMS86378Issued (active) · Class 2
LITHIUM FOR COBAS C SYSTEMS86379Issued (active) · Class 2
SALICYLATE TEST KITS86230Issued (active) · Class 2
PRECICONTROL CLINCHEM MULTI CONTROLS85801Issued (active) · Class 3
METHADONE II85774Issued (active) · Class 2
HGH (HUMAN GROWTH HORMONE) - IMMUNOASSAY85754Issued (active) · Class 2
COBAS ACETAMINOPHEN CALIBRATOR85581Issued (active) · Class 2
CANNABINOIDS II85582Issued (active) · Class 2
ACETAMINOPHEN85586Issued (active) · Class 2
KAPPA LIGHT CHAIN TEST KITS85071Issued (active) · Class 2
ANTITHROMBIN TEST KITS85072Issued (active) · Class 2
LAMBDA LIGHT CHAIN TEST KITS85073Issued (active) · Class 2
CERU CERULOPLASMIN84041Issued (active) · Class 2
PREALBUMIN TEST KITS83918Issued (active) · Class 2
HAPTOGLOBIN TEST KITS83919Issued (active) · Class 2
ULTRA VIEW SISH DNP DETECTION KIT83761Issued (active) · Class 2
PRECICONTROL TROPONIN83319Issued (active) · Class 3
PRECICONTROL HIV82957Issued (active) · Class 4
CMV IGM82960Issued (active) · Class 3
HBA1C CONTROLS82701Issued (active) · Class 2
COBAS INSTRUMENT SOFTWARE82702Issued (active) · Class 2
PRECICONTROL CMV IGG82636Issued (active) · Class 3
CMV IGG82601Issued (active) · Class 3
PLGF (PLACENTAL GROWTH FACTOR)82580Issued (active) · Class 3
SFLT-1 (SOLUABLE FMS-LIKE TYROSINE KINASE-1)82584Issued (active) · Class 3
TOTAL MYCOPHENOLIC CALIBRATORS82334Issued (active) · Class 3
TOTAL MYCOPHENOLIC ACID CONTROLS82335Issued (active) · Class 3
MYCOPHENOLIC ACID82336Issued (active) · Class 3
SERUM PROTEINS T STANDARD82309Issued (active) · Class 2
IGM (IMMUNOGLOBULIN M)82078Issued (active) · Class 2
IGA (IMMUNOGLOBULIN A)82079Issued (active) · Class 2
IGG (IMMUNOGLOBULIN G)82080Issued (active) · Class 2
MULTI CONTROLS FOR ROCHE CHEMISTRY ANALYZERS81740Issued (active) · Class 2
PATIENT MANAGEMENT SOFTWARE81175Issued (active) · Class 2
BENZODIAZEPINES II ASSAY81046Issued (active) · Class 2
ACCU-CHEK PERFORMA BLOOD GLUCOSE METER80959Issued (active) · Class 3
ANTI-HCV TEST KIT80777Issued (active) · Class 4
TESTOSTERONE CALIBRATORS80630Issued (active) · Class 2
AMPHETAMINES ASSAY80345Issued (active) · Class 2
CONTROL SET DAT CLINICAL (DRUGS OF ABUSE)80346Issued (active) · Class 2
CARDIAC CONTROL PROBNP80264Issued (active) · Class 3
D-DIMER CALIBRATORS80181Issued (active) · Class 2
D-DIMER CONTROL80182Issued (active) · Class 2
D-DIMER (D-DI)80091Issued (active) · Class 2
TOXO IGM TEST KIT78781Issued (active) · Class 3
RUBELLA IGM TEST KITS78767Issued (active) · Class 3
IL-6 (INTERLEUKIN-6) TEST KITS78753Issued (active) · Class 2
LSD TEST KITS78575Issued (active) · Class 2
LSD CAL/CONTROL PACK78576Issued (active) · Class 2
RUBELLA IGG TEST KIT77926Issued (active) · Class 3
CYSTATIN C CONTROL77852Issued (active) · Class 2
TOXO IGG77768Issued (active) · Class 3
CYSTATIN C77690Issued (active) · Class 2
PROCALCITONIN77691Issued (active) · Class 2
GLDH (GLUTAMATE DEHYDROGENASE)77655Issued (active) · Class 2
ION SELECTIVE ELECTRODE ANALYZER MODULES77399Issued (active) · Class 2
CHOLESTEROL TEST STRIPS77191Issued (active) · Class 2
CHOLESTEROL CONTROL STRIPS77198Issued (active) · Class 2
ANTI-CCP TEST KIT76882Issued (active) · Class 2
CARBAMAZEPINE76859Issued (active) · Class 2
PHENOBARBITAL76860Issued (active) · Class 2
N-ACETYL PROCAINAMIDE76861Issued (active) · Class 2
PROCAINAMIDE76862Issued (active) · Class 2
PHENYTOIN76863Issued (active) · Class 2
THEOPHYLLINE76864Issued (active) · Class 2
VALPROIC ACID76865Issued (active) · Class 2
TOBRAMYCIN76866Issued (active) · Class 2
GENTAMICIN76867Issued (active) · Class 2
(HBDH2) ALPHA-HYDROXYBUTYRATE DEHYDROGENASE (KETONES)76868Issued (active) · Class 2
SODIUM (NA)76869Issued (active) · Class 2
CHLORIDE (CI)76870Issued (active) · Class 2
POTASSIUM (K)76871Issued (active) · Class 2
REFERENCE ELECTRODE76872Issued (active) · Class 2
ISE CALIBRATION SOLUTIONS76873Issued (active) · Class 2
ANTI-TSH RECEPTOR76847Issued (active) · Class 2
CHEMISTRY ANALYZERS76421Issued (active) · Class 3
TOTAL PROTEIN URINE/CSF76413Issued (active) · Class 2
ALCOHOL ASSAY76414Issued (active) · Class 2
ALPHA-1 ACID GLYCOPROTEIN76415Issued (active) · Class 2
ALPHA-A ANTITRYPSIN76416Issued (active) · Class 2
ANTI-STREPTOLYSIN O (ASLO)76417Issued (active) · Class 2
LACTATE76419Issued (active) · Class 2
ACID PHOSPHATASE (ACP)76420Issued (active) · Class 2
FRUCTOSAMINE76390Issued (active) · Class 2
MAGNESIUM (MG)76394Issued (active) · Class 2
APOLIPOPROTEIN A-176396Issued (active) · Class 2
APOLIPOPROTEIN B76398Issued (active) · Class 2
RHEUMATOID FACTOR (RF)76399Issued (active) · Class 2
COMPLEMENT C476400Issued (active) · Class 2
UNSATURATED IRON-BINDING CAPACITY (UIBC)76401Issued (active) · Class 2
CHOLINESTERASE (CHE)76402Issued (active) · Class 2
IRON76403Issued (active) · Class 2
TRANSFERRIN76404Issued (active) · Class 2
MICROALBUMIN76251Issued (active) · Class 2
NEAR PATIENT D-DIMER74672Issued (active) · Class 3
CARDIAC MARKER CONTROLS74673Issued (active) · Class 3
NEAR PATIENT IMMUNOASSAY INSTRUMENTS74674Issued (active) · Class 3
CK-NAC74371Issued (active) · Class 2
GAMMA-GLUTAMYLTRANSFERASE (GGT)74373Issued (active) · Class 2
CREATININE74414Issued (active) · Class 2
ALKALINE PHOSPHATASE (ALP)74369Issued (active) · Class 2
ALANINE AMINOTRANSFERASE (ALT)74370Issued (active) · Class 2
ASPARTATE AMINOTRANSFERASE74372Issued (active) · Class 2
PHOSPHORUS74374Issued (active) · Class 2
TRIGLYCERIDES (TG)74375Issued (active) · Class 2
CALCIUM (CA)74376Issued (active) · Class 2
BICARBONATE74377Issued (active) · Class 2
GLUCOSE74378Issued (active) · Class 2
HEMOGLOBIN A1C (HBA1C)74379Issued (active) · Class 2
COMPLEMENT C374380Issued (active) · Class 2
LACTATE DEHYDROGENASE (LDH)74381Issued (active) · Class 2
TOTAL PROTEIN (TP)74382Issued (active) · Class 2
LIPASE74383Issued (active) · Class 2
C-REACTIVE PROTEIN (CRP)74384Issued (active) · Class 2

Showing 300 of 573 licences. For the rest, search Health Canada’s database.

Recalls and safety alerts that mention its products

Health Canada’s recall notices do not carry licence numbers, so these are matched by name. A notice may cover another product or only some lots: read it to see what it covers.