Manufacturer's Devices - Roche Molecular Systems Inc.

Address:




Roche Molecular Systems Inc. 1080 US Highway 202 South



Branchburg

NJ 08876

United States


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
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayHIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
HIV1/HIV2 nucleic acid IVD controlHIV1/HIV2 nucleic acid IVD controlIVD Annex II List A
PCR/NAT negative control IVDPCR/NAT negative control IVDIVD Annex II List A
Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD controlIVD Annex II List A
Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Laboratory container robotic transfer system IVDLaboratory container robotic transfer system IVDClass A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Class B
Nucleic acid hybridization detection IVD kitNucleic acid hybridization detection IVD kitIVD General
Exogenous DNA/RNA internal control IVD kitExogenous DNA/RNA internal control IVD kitIVD General
Nucleic acid sample preparation instrument IVD semi-automatedNucleic acid sample preparation instrument IVD semi-automatedIVD General
MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple immunocompromised host infection-associated virus nucleic acid IVD controlMultiple immunocompromised host infection-associated virus nucleic acid IVD controlIVD General
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalIVD General
MRSA/MSSA nucleic acid IVD controlMRSA/MSSA nucleic acid IVD controlIVD General
General specimen container IVD additive/mediumGeneral specimen container IVD additive/mediumIVD General
MRSA phenotype detection IVD kit bioassayMRSA phenotype detection IVD kit bioassayIVD General
Human papillomavirus (HPV) nucleic acid IVD controlHuman papillomavirus (HPV) nucleic acid IVD controlIVD General
Slide-mounted-tissue dissection system IVDSlide-mounted-tissue dissection system IVDIVD General
Human genomic analysis interpretive softwareHuman genomic analysis interpretive softwareIVD General
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass I
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass IIa
Inherited thrombophilia IVD kit nucleic acid technique (NAT)Inherited thrombophilia IVD kit nucleic acid technique (NAT)IVD General
Basic/simple nutrient broth culture medium IVDBasic/simple nutrient broth culture medium IVDIVD General
Non-evacuated urine specimen container IVD no additiveNon-evacuated urine specimen container IVD no additiveIVD General
Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT)Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlIVD General
Specimen processing instrument IVDSpecimen processing instrument IVDIVD General
Optical instrument performance standard calibrator/control IVD single-useOptical instrument performance standard calibrator/control IVD single-useIVD General
Urine specimen collection kit IVDUrine specimen collection kit IVDIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Microplate IVDMicroplate IVDClass A
General specimen container IVD additive/mediumGeneral specimen container IVD additive/mediumClass A
MRSA/MSSA nucleic acid IVD controlMRSA/MSSA nucleic acid IVD controlClass C
Inherited thrombophilia IVD kit nucleic acid technique (NAT)Inherited thrombophilia IVD kit nucleic acid technique (NAT)Class C
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Class B
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Class C
Slide-mounted-tissue dissection system IVDSlide-mounted-tissue dissection system IVDClass A
Specimen processing instrument IVDSpecimen processing instrument IVDClass A
Nucleic acid amplification mastermix kit IVDNucleic acid amplification mastermix kit IVDClass A
Evacuated blood collection tube IVD nucleic acid stabilizerEvacuated blood collection tube IVD nucleic acid stabilizerClass A
Exogenous DNA/RNA internal control IVD kitExogenous DNA/RNA internal control IVD kitClass A
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemClass A
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemClass A
Assay adhesive sealing/fixation film IVDAssay adhesive sealing/fixation film IVDClass A
Test tube/reservoir cap IVDTest tube/reservoir cap IVDClass A
MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)Class C
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)Class C
Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Class C
Urine specimen collection kit IVDUrine specimen collection kit IVDClass A
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalClass A
Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)Class C
Multiple immunocompromised host infection-associated virus nucleic acid IVD controlMultiple immunocompromised host infection-associated virus nucleic acid IVD controlClass C
BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)Class C
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDClass A
Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Class C
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Class B
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlClass B
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Class B
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlClass B
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Class C
Non-evacuated urine specimen container IVD no additiveNon-evacuated urine specimen container IVD no additiveClass A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryClass A
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDClass A
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDClass A
PCR/NAT negative control IVDPCR/NAT negative control IVDClass A
Instrument/analyser specimen/reagent container carrier IVDInstrument/analyser specimen/reagent container carrier IVDClass A
Assay container IVD single-useAssay container IVD single-useClass A
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumClass A
Pipette tip IVDPipette tip IVDClass A
Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple respiratory virus nucleic acid IVD reagentMultiple respiratory virus nucleic acid IVD reagentIVD General
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General