Manufacturer's Devices - SD Biosensor Inc.

Address:




C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea



Suwon-si

16690

South Korea


Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street



Oxford

OX1 2EP

England United Kingdom




Code/Term Type
Total cholesterol lipid IVD reagentTotal cholesterol lipid IVD reagentIVD Annex II List B
Glucose/ketone/lipid profile IVD reagentGlucose/ketone/lipid profile IVD reagentIVD Annex II List B
Triglyceride IVD reagentTriglyceride IVD reagentIVD Annex II List B
Glucose/ketone/lipid profile IVD controlGlucose/ketone/lipid profile IVD controlIVD Annex II List B
SARS-CoV-2 antigen IVD kit rapid ICT self-testingSARS-CoV-2 antigen IVD kit rapid ICT self-testingIVD Devices for Self-Testing
Glucose analyser IVD home-useGlucose analyser IVD home-useIVD Annex II List B
Glucose IVD reagentGlucose IVD reagentIVD Annex II List B
Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapidGlycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapidIVD General
Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayZika virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayIVD General
Multiple tropical viral pathogen antigen/antibody IVD kit rapid ICT clinicalMultiple tropical viral pathogen antigen/antibody IVD kit rapid ICT clinicalIVD General
Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalZika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Fluorescent immunoassay analyser IVD laboratory semi-automatedFluorescent immunoassay analyser IVD laboratory semi-automatedIVD General
Faecal occult blood IVD kit rapid ICT clinicalFaecal occult blood IVD kit rapid ICT clinicalIVD General
Multiple Plasmodium species antigen IVD kit rapid ICT clinicalMultiple Plasmodium species antigen IVD kit rapid ICT clinicalIVD General
Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD reagentOrientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD reagentIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Dengue virus NS1 antigen IVD reagentDengue virus NS1 antigen IVD reagentIVD General
Helicobacter pylori antigen IVD kit rapid ICT clinicalHelicobacter pylori antigen IVD kit rapid ICT clinicalIVD General
Dengue virus NS1 antigen IVD controlDengue virus NS1 antigen IVD controlIVD General
Clostridium difficile antigen IVD kit fluorescent immunoassay rapidClostridium difficile antigen IVD kit fluorescent immunoassay rapidIVD General
Zika virus antigen IVD kit fluorescent immunoassay rapidZika virus antigen IVD kit fluorescent immunoassay rapidIVD General
Luteinizing hormone (LH) IVD kit fluorescent immunoassay rapidLuteinizing hormone (LH) IVD kit fluorescent immunoassay rapidIVD General
Multiple respiratory virus antigen IVD kit rapid ICT clinicalMultiple respiratory virus antigen IVD kit rapid ICT clinicalIVD General
Respiratory syncytial virus (RSV) antigen IVD kit fluorescent immunoassayRespiratory syncytial virus (RSV) antigen IVD kit fluorescent immunoassayIVD General
Influenza A/B virus antigen IVD kit fluorescent immunoassayInfluenza A/B virus antigen IVD kit fluorescent immunoassayIVD General
Legionella pneumophila antigen IVD kit fluorescent immunoassayLegionella pneumophila antigen IVD kit fluorescent immunoassayIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassayBeta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassayIVD General
Streptococcus pneumoniae antigen IVD kit fluorescent immunoassayStreptococcus pneumoniae antigen IVD kit fluorescent immunoassayIVD General
Thermal cycler nucleic acid amplification analyser IVD point-of-careThermal cycler nucleic acid amplification analyser IVD point-of-careIVD General
Multiple tropical viral pathogen immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalMultiple tropical viral pathogen immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Dengue virus antigen/antibody IVD kit rapid ICT clinicalDengue virus antigen/antibody IVD kit rapid ICT clinicalIVD General
Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit rapid ICT clinicalDengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit rapid ICT clinicalIVD General
Dengue virus antigen IVD kit rapid ICT clinicalDengue virus antigen IVD kit rapid ICT clinicalIVD General
Procalcitonin (PCT) IVD kit fluorescent immunoassayProcalcitonin (PCT) IVD kit fluorescent immunoassayIVD General
Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Zika virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Zika virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus antigen IVD kit enzyme immunoassay (EIA)Dengue virus antigen IVD kit enzyme immunoassay (EIA)IVD General
C-reactive protein (CRP) IVD controlC-reactive protein (CRP) IVD controlIVD General
Glycated haemoglobin (HbA1c) IVD controlGlycated haemoglobin (HbA1c) IVD controlIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD controlCreatine kinase myocardial isoenzyme (CKMB) IVD controlIVD General
D-dimer IVD controlD-dimer IVD controlIVD General
Luteinizing hormone (LH) IVD controlLuteinizing hormone (LH) IVD controlIVD General
Ebola virus antigen IVD kit rapid ICT clinicalEbola virus antigen IVD kit rapid ICT clinicalIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD controlIVD General
Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD controlDengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD controlIVD General
Interferon gamma release IVD controlInterferon gamma release IVD controlIVD General
Free thyroxine (FT4) IVD controlFree thyroxine (FT4) IVD controlIVD General
Faecal occult blood IVD controlFaecal occult blood IVD controlIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD controlIVD General
Total thyroxine (TT4) IVD controlTotal thyroxine (TT4) IVD controlIVD General
Multiple mosquito-borne flavivirus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalMultiple mosquito-borne flavivirus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
Interferon gamma release IVD kit fluorescent immunoassayInterferon gamma release IVD kit fluorescent immunoassayIVD General
Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayMultiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayIVD General
Legionella pneumophila antigen IVD kit rapid ICT clinicalLegionella pneumophila antigen IVD kit rapid ICT clinicalIVD General
Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalMultiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassayDengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassayIVD General
Chikungunya virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayChikungunya virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayIVD General
Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassayOrientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassayIVD General
Adenovirus antigen IVD kit fluorescent immunoassayAdenovirus antigen IVD kit fluorescent immunoassayIVD General
Free thyroxine (FT4) IVD kit fluorescent immunoassayFree thyroxine (FT4) IVD kit fluorescent immunoassayIVD General
Total thyroxine (TT4) IVD kit fluorescent immunoassayTotal thyroxine (TT4) IVD kit fluorescent immunoassayIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Multiple-type gastrointestinal pathogen antigen IVD kit fluorescent immunoassayMultiple-type gastrointestinal pathogen antigen IVD kit fluorescent immunoassayIVD General
Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVDHaemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVDIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassaySARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassayIVD General
Helicobacter pylori antigen IVD kit fluorescent immunoassay rapidHelicobacter pylori antigen IVD kit fluorescent immunoassay rapidIVD General
Evacuated blood collection tube IVD anticoagulantEvacuated blood collection tube IVD anticoagulantIVD General
SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA)SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA)IVD General
Multiple Plasmodium species antigen IVD kit enzyme immunoassay (EIA)Multiple Plasmodium species antigen IVD kit enzyme immunoassay (EIA)IVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD controlHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD controlIVD General
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD controlRed cell glucose-6-phosphate dehydrogenase (G6PD) IVD controlIVD General
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme spectrophotometryRed cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme spectrophotometryIVD General
Multiple form 25-hydroxy Vitamin D IVD controlMultiple form 25-hydroxy Vitamin D IVD controlIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Wuchereria bancrofti antigen IVD kit rapid ICT clinicalWuchereria bancrofti antigen IVD kit rapid ICT clinicalIVD General
Hepatitis A virus antigen IVD kit rapid ICT clinicalHepatitis A virus antigen IVD kit rapid ICT clinicalIVD General
Norovirus antigen IVD kit rapid ICT clinicalNorovirus antigen IVD kit rapid ICT clinicalIVD General
Troponin I IVD kit rapid ICT clinicalTroponin I IVD kit rapid ICT clinicalIVD General
Capillary blood collection tube IVD no additiveCapillary blood collection tube IVD no additiveIVD General
Treponema pallidum total antibody IVD kit rapid ICT clinicalTreponema pallidum total antibody IVD kit rapid ICT clinicalIVD General
Treponema pallidum total antibody IVD controlTreponema pallidum total antibody IVD controlIVD General
Helicobacter pylori antigen IVD controlHelicobacter pylori antigen IVD controlIVD General
Treponema pallidum total antibody IVD kit fluorescent immunoassayTreponema pallidum total antibody IVD kit fluorescent immunoassayIVD General
Thyroid stimulating hormone (TSH) IVD controlThyroid stimulating hormone (TSH) IVD controlIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassayB-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassayIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassayCreatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassayIVD General
D-dimer IVD kit fluorescent immunoassayD-dimer IVD kit fluorescent immunoassayIVD General
SARS-CoV-2/influenza A/B antigen IVD controlSARS-CoV-2/influenza A/B antigen IVD controlIVD General
Plasmodium falciparum antigen IVD kit rapid ICT clinicalPlasmodium falciparum antigen IVD kit rapid ICT clinicalIVD General
Multiple gastrointestinal virus antigen IVD kit rapid ICT clinicalMultiple gastrointestinal virus antigen IVD kit rapid ICT clinicalIVD General
Rotavirus antigen IVD kit rapid ICT clinicalRotavirus antigen IVD kit rapid ICT clinicalIVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Streptococcus pneumoniae antigen IVD kit rapid ICT clinicalStreptococcus pneumoniae antigen IVD kit rapid ICT clinicalIVD General
C-reactive protein (CRP) IVD kit fluorescent immunoassayC-reactive protein (CRP) IVD kit fluorescent immunoassayIVD General
Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayThyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayIVD General
Influenza virus/respiratory syncytial virus (RSV) antigen IVD controlInfluenza virus/respiratory syncytial virus (RSV) antigen IVD controlIVD General
Legionella pneumophila antigen IVD controlLegionella pneumophila antigen IVD controlIVD General
Beta-haemolytic Group A Streptococcus antigen IVD controlBeta-haemolytic Group A Streptococcus antigen IVD controlIVD General
Streptococcus pneumoniae antigen IVD controlStreptococcus pneumoniae antigen IVD controlIVD General
Respiratory syncytial virus (RSV) antigen IVD controlRespiratory syncytial virus (RSV) antigen IVD controlIVD General
Interferon IVD kit enzyme immunoassay (EIA)Interferon IVD kit enzyme immunoassay (EIA)IVD General
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Multiple form 25-hydroxy vitamin D IVD kit fluorescent immunoassay rapidMultiple form 25-hydroxy vitamin D IVD kit fluorescent immunoassay rapidIVD General
Total triiodothyronine (TT3) IVD kit fluorescent immunoassayTotal triiodothyronine (TT3) IVD kit fluorescent immunoassayIVD General
Albumin IVD kit fluorescent immunoassayAlbumin IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinicalSARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinicalIVD General
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassayIVD General
Multidrug-resistant nontuberculous Mycobacterium (NTM) nucleic acid IVD kit nucleic acid technique (NAT)Multidrug-resistant nontuberculous Mycobacterium (NTM) 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
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)IVD General
MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT)MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type tropical pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type tropical pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Follicle stimulating hormone (FSH) IVD controlFollicle stimulating hormone (FSH) IVD controlIVD General
Norovirus antigen IVD controlNorovirus antigen IVD controlIVD General
Multiple gastrointestinal virus antigen IVD controlMultiple gastrointestinal virus antigen IVD controlIVD General
Influenza A/B virus antigen IVD controlInfluenza A/B virus antigen IVD controlIVD General
Adenovirus antigen IVD controlAdenovirus antigen IVD controlIVD General
Mycoplasma pneumoniae antigen IVD controlMycoplasma pneumoniae antigen IVD controlIVD General
Mycoplasma pneumoniae total antibody IVD kit fluorescent immunoassayMycoplasma pneumoniae total antibody IVD kit fluorescent immunoassayIVD General
Mycoplasma pneumoniae total antibody IVD controlMycoplasma pneumoniae total antibody IVD controlIVD General
Total triiodothyronine (TT3) IVD controlTotal triiodothyronine (TT3) IVD controlIVD General
Mycoplasma pneumoniae antigen IVD kit rapid ICT clinicalMycoplasma pneumoniae antigen IVD kit rapid ICT clinicalIVD General
SARS-CoV-2 neutralizing antibody IVD controlSARS-CoV-2 neutralizing antibody IVD controlIVD General
Follicle stimulating hormone (FSH) IVD kit rapid ICT clinicalFollicle stimulating hormone (FSH) IVD kit rapid ICT clinicalIVD General
Microalbumin IVD controlMicroalbumin 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
Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalMycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalIVD General
Multiple cardiac marker IVD kit fluorescent immunoassayMultiple cardiac marker IVD kit fluorescent immunoassayIVD General
Troponin I IVD controlTroponin I IVD controlIVD General
Troponin I IVD kit fluorescent immunoassayTroponin I IVD kit fluorescent immunoassayIVD 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
Mycobacterium tuberculosis complex species antigen IVD controlMycobacterium tuberculosis complex species antigen IVD controlIVD General
SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalSARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinicalIVD General
PCR instrument calibrator kit IVDPCR instrument calibrator kit IVDIVD General
Sputum specimen liquefaction/decontamination kit IVDSputum specimen liquefaction/decontamination kit IVDIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Faecal specimen container IVD transport buffer/mediumFaecal specimen container IVD transport buffer/mediumIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careClass A
Fluorescent immunoassay analyser IVD point-of-careFluorescent immunoassay analyser IVD point-of-careIVD General