Manufacturer's Devices - Roche Diagnostics GmbH

Address:




Sandhofer Strasse 116



Mannheim

68305

Germany


Authorised Representative/ UK Responsible Person
Name: Roche Diagnostics Limited
Address:

Roche Diagnostics Limited Charles Avenue



Burgess Hill

West Sussex RH15 9RY

United Kingdom




Code/Term Type
Coagulation analyser IVD laboratoryCoagulation analyser IVD laboratoryClass A
Plasma protein IVD calibratorPlasma protein IVD calibratorClass B
Multi-modality clinical specimen analysis system IVDMulti-modality clinical specimen analysis system IVDClass A
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayClass C
Total cortisol IVD calibratorTotal cortisol IVD calibratorClass B
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Coagulation analyser IVD point-of-care battery-poweredCoagulation analyser IVD point-of-care battery-poweredIVD General
Troponin I IVD kit rapid ICT clinicalTroponin I IVD kit rapid ICT clinicalIVD General
Alpha-fetoprotein (AFP) IVD calibratorAlpha-fetoprotein (AFP) IVD calibratorClass C
Holotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayHolotranscobalamin (holoTC) IVD kit chemiluminescent immunoassayClass B
Holotranscobalamin (holoTC) IVD controlHolotranscobalamin (holoTC) IVD controlClass B
Anti-Mullerian hormone (AMH) IVD calibratorAnti-Mullerian hormone (AMH) IVD calibratorClass C
Anti-Mullerian hormone (AMH) IVD controlAnti-Mullerian hormone (AMH) IVD controlClass C
Zika virus nucleic acid IVD controlZika virus nucleic acid IVD controlClass C
Single-channel clinical chemistry analyser IVD point-of-careSingle-channel clinical chemistry analyser IVD point-of-careIVD General
Myosin light chain IVD controlMyosin light chain IVD controlClass C
Multiple drugs of abuse IVD calibratorMultiple drugs of abuse IVD calibratorClass B
Total testosterone IVD kit chemiluminescent immunoassayTotal testosterone IVD kit chemiluminescent immunoassayClass B
Troponin T IVD reagentTroponin T IVD reagentClass C
Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Mycophenolate therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Class C
Holotranscobalamin (holoTC) IVD calibratorHolotranscobalamin (holoTC) IVD calibratorClass B
Total cortisol IVD kit chemiluminescent immunoassayTotal cortisol IVD kit chemiluminescent immunoassayClass B
Cancer antigen 72-4 (CA72-4) IVD calibratorCancer antigen 72-4 (CA72-4) IVD calibratorClass C
Des-gamma-carboxyprothrombin (DCP) IVD kit chemiluminescent immunoassayDes-gamma-carboxyprothrombin (DCP) IVD kit chemiluminescent immunoassayClass C
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryClass B
Laboratory waste receptacle liner IVDLaboratory waste receptacle liner IVDClass A
Hepatitis C virus total antibody IVD kit chemiluminescent assayHepatitis C virus total antibody IVD kit chemiluminescent assayIVD Annex II List A
Free testosterone IVD calibratorFree testosterone IVD calibratorClass B
Procollagen type I N-terminal propeptide (PINP) IVD calibratorProcollagen type I N-terminal propeptide (PINP) IVD calibratorClass B
Troponin T/Troponin I IVD controlTroponin T/Troponin I IVD controlClass C
Folate (vitamin B9) IVD reagentFolate (vitamin B9) IVD reagentClass A
Adrenocorticotropic hormone (ACTH) IVD calibratorAdrenocorticotropic hormone (ACTH) IVD calibratorClass B
Thyroid stimulating hormone receptor (TSHR) antibody IVD calibratorThyroid stimulating hormone receptor (TSHR) antibody IVD calibratorClass B
Ferritin IVD calibratorFerritin IVD calibratorClass B
Total cortisol IVD controlTotal cortisol IVD controlClass B
Thyroid stimulating hormone (TSH) IVD calibratorThyroid stimulating hormone (TSH) IVD calibratorClass B
Vitamin B12 IVD calibratorVitamin B12 IVD calibratorClass B
Cancer antigen 15-3 (CA15-3) IVD calibratorCancer antigen 15-3 (CA15-3) IVD calibratorClass C
Des-gamma-carboxyprothrombin (DCP) IVD calibratorDes-gamma-carboxyprothrombin (DCP) IVD calibratorClass C
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorCyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorClass C
Cytokeratin IVD calibratorCytokeratin IVD calibratorClass C
Cancer antigen 125 (CA125) IVD kit enzyme immunoassay (EIA)Cancer antigen 125 (CA125) IVD kit enzyme immunoassay (EIA)Class C
Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayCancer antigen 125 (CA125) IVD kit chemiluminescent immunoassayClass C
Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayCancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassayClass C
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD reagentCyclosporin A/cyclosporine therapeutic drug monitoring IVD reagentClass C
Cyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayClass C
Neuron-specific enolase (NSE) IVD kit enzyme immunoassay (EIA)Neuron-specific enolase (NSE) IVD kit enzyme immunoassay (EIA)Class C
Tacrolimus therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Tacrolimus therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Class C
Tacrolimustherapeutic drug monitoring IVD kit chemiluminescent immunoassayTacrolimustherapeutic drug monitoring IVD kit chemiluminescent immunoassayClass C
Zika virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayZika virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayClass C
Human epididymis protein 4 (HE4) IVD calibratorHuman epididymis protein 4 (HE4) IVD calibratorClass C
Neuron-specific enolase (NSE) IVD calibratorNeuron-specific enolase (NSE) IVD calibratorClass C
Hepatitis A virus immunoglobulin M (IgM) antibody IVD controlHepatitis A virus immunoglobulin M (IgM) antibody IVD controlClass C
Des-gamma-carboxyprothrombin (DCP) IVD controlDes-gamma-carboxyprothrombin (DCP) IVD controlClass C
Human epididymis protein 4 (HE4) IVD controlHuman epididymis protein 4 (HE4) IVD controlClass C
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD controlClass C
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlClass C
Squamous cell carcinoma antigen IVD calibratorSquamous cell carcinoma antigen IVD calibratorClass C
Tacrolimus therapeutic drug monitoring IVD calibratorTacrolimus therapeutic drug monitoring IVD calibratorClass C
Instrument/analyser test tube rack adaptor IVDInstrument/analyser test tube rack adaptor IVDClass A
Reference electrode IVDReference electrode IVDClass A
Chloride (Cl-) electrode IVDChloride (Cl-) electrode IVDClass B
Potassium (K+) IVD kit ion-selective electrode (ISE)Potassium (K+) IVD kit ion-selective electrode (ISE)Class B
Sodium (Na+) electrode IVDSodium (Na+) electrode IVDClass B
Chemiluminescent immunoassay analyser IVDChemiluminescent immunoassay analyser IVDClass A
PIK3CA gene mutation IVD kit nucleic acid technique (NAT)PIK3CA gene mutation IVD kit nucleic acid technique (NAT)Class C
Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)Class C
Multiple Mycobacterium species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Mycobacterium species nucleic acid IVD kit nucleic acid technique (NAT)Class C
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Glucose analyser IVD point-of-careGlucose analyser IVD point-of-careIVD General
Glucose IVD controlGlucose IVD controlIVD General
Trypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayTrypanosoma cruzi total antibody IVD kit chemiluminescent immunoassayIVD General
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD kit chemiluminescent immunoassayHuman T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorClass A
Buffered sample diluent IVD manualBuffered sample diluent IVD manualClass A
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemClass A
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDIVD General
Pipette tip IVDPipette tip IVDClass A
Laboratory waste receptacle IVDLaboratory waste receptacle IVDIVD General
Glucose IVD reagentGlucose IVD reagentIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDClass A
Metabolic profile clinical chemistry analyser IVDMetabolic profile clinical chemistry analyser IVDClass A
Nucleic acid hybridization detection IVD reagentNucleic acid hybridization detection IVD reagentClass A
Photometric/spectroscopic immunoassay analyser IVDPhotometric/spectroscopic immunoassay analyser IVDClass A
Urine analyser IVD laboratoryUrine analyser IVD laboratoryClass A
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDClass A
Coagulation analyser IVD laboratory semi-automatedCoagulation analyser IVD laboratory semi-automatedClass A
Instrument/analyser specimen/reagent container carrier IVDInstrument/analyser specimen/reagent container carrier IVDClass A
Multiple Mycobacterium species nucleic acid IVD reagentMultiple Mycobacterium species nucleic acid IVD reagentClass A
Cytology specimen container IVD transport bufferCytology specimen container IVD transport bufferClass A
Syringe/blood collection tube adaptor IVDSyringe/blood collection tube adaptor IVDClass A
Test tube/reservoir cap IVDTest tube/reservoir cap IVDClass A
Assay container IVD single-useAssay container IVD single-useClass A
Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayTotal prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Pregnancy-associated plasma protein A (PAPP-A) IVD reagentPregnancy-associated plasma protein A (PAPP-A) IVD reagentIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayFree (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassayIVD Annex II List B
Glucose analyser IVD point-of-careGlucose analyser IVD point-of-careClass A
Specimen processing instrument IVDSpecimen processing instrument IVDClass A
Interferon gamma release IVD kit enzyme immunoassay (EIA)Interferon gamma release IVD kit enzyme immunoassay (EIA)IVD General
Interferon gamma release IVD calibratorInterferon gamma release IVD calibratorIVD General
Interferon gamma release IVD controlInterferon gamma release IVD controlIVD General
Interferon gamma release IVD reagentInterferon gamma release IVD reagentIVD General