Manufacturer's Devices - Abbott Diagnostics Scarborough Inc.

Address:




10 Southgate Rd



Scarborough

Maine 04074

United States


Authorised Representative/ UK Responsible Person
Name: Unipath Limited (trading as Alere International)
Address:

Clearblue Innovation Centre Priory Business Park

Stannard Way

Bedford

Bedfordshire MK44 3UP

England United Kingdom




Code/Term Type
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Multiple Plasmodium species antigen IVD controlMultiple Plasmodium species antigen IVD controlIVD General
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD 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
Immunoassay reagent vehicle tray IVD reusableImmunoassay reagent vehicle tray IVD reusableIVD General
Optical instrument performance standard calibrator/control IVD reusableOptical instrument performance standard calibrator/control IVD reusableIVD General
Nuclear matrix protein 22 IVD reagentNuclear matrix protein 22 IVD reagentIVD General
Wuchereria bancrofti antigen IVD kit rapid ICT clinicalWuchereria bancrofti antigen IVD kit rapid ICT clinicalIVD General
Photometric/spectroscopic immunoassay analyser IVDPhotometric/spectroscopic immunoassay analyser IVDIVD 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
Influenza A/B virus nucleic acid IVD controlInfluenza A/B virus nucleic acid IVD controlIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Influenza A/B virus antigen IVD controlInfluenza A/B virus antigen IVD controlIVD General
Respiratory syncytial virus (RSV) nucleic acid IVD kit nucleic acid technique (NAT)Respiratory syncytial virus (RSV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Legionella pneumophila antigen IVD kit rapid ICT clinicalLegionella pneumophila antigen IVD kit rapid ICT clinicalIVD General
Legionella pneumophila antigen IVD kit enzyme immunoassay (EIA)Legionella pneumophila antigen IVD kit enzyme immunoassay (EIA)IVD General
Legionella pneumophila antigen IVD controlLegionella pneumophila antigen IVD controlIVD General
Legionella pneumophila antigen IVD reagentLegionella pneumophila antigen IVD reagentIVD 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
Streptococcus pneumoniae antigen IVD kit rapid ICT clinicalStreptococcus pneumoniae antigen IVD kit rapid ICT clinicalIVD General
Streptococcus pneumoniae antigen IVD controlStreptococcus pneumoniae antigen IVD controlIVD General
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit rapid ICT clinicalRed cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit rapid ICT clinicalIVD General
Nuclear matrix protein 22 IVD kit enzyme immunoassay (EIA)Nuclear matrix protein 22 IVD kit enzyme immunoassay (EIA)IVD General
Nuclear matrix protein 22 IVD kit rapid ICT clinicalNuclear matrix protein 22 IVD kit rapid ICT clinicalIVD General
Nuclear matrix protein 22 IVD controlNuclear matrix protein 22 IVD controlIVD General
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryIVD General
Respiratory syncytial virus (RSV) antigen IVD controlRespiratory syncytial virus (RSV) antigen IVD controlIVD General
Respiratory syncytial virus (RSV) nucleic acid IVD controlRespiratory syncytial virus (RSV) nucleic acid IVD controlIVD General
Beta-haemolytic Group A Streptococcus antigen IVD controlBeta-haemolytic Group A Streptococcus antigen IVD controlIVD General
Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalMycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalIVD General
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD kitBacterial species culture isolate identification/antimicrobial susceptibility profile IVD kitIVD General
Multiple Plasmodium species antigen IVD kit rapid ICT clinicalMultiple Plasmodium species antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Protease IVD kit rapid ICT clinicalProtease IVD kit rapid ICT clinicalIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General