| SARS-CoV-2 antigen IVD kit rapid ICT self-testing | SARS-CoV-2 antigen IVD kit rapid ICT self-testing | IVD Devices for Self-Testing
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| SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical | SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical | IVD General
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| Procalcitonin (PCT) IVD kit rapid ICT clinical | Procalcitonin (PCT) IVD kit rapid ICT clinical | IVD General
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| SARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassay | SARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassay | IVD General
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| SARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapid | SARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapid | IVD General
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| Multiple form 25-hydroxy Vitamin D IVD reagent | Multiple form 25-hydroxy Vitamin D IVD reagent | IVD General
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| Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassay | Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassay | IVD General
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| Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapid | Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapid | IVD General
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| Influenza/parainfluenza virus antigen IVD kit immunochromatographic test (ICT) rapid | Influenza/parainfluenza virus antigen IVD kit immunochromatographic test (ICT) rapid | IVD General
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| Helicobacter pylori antigen IVD kit rapid ICT clinical | Helicobacter pylori antigen IVD kit rapid ICT clinical | IVD General
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| Cystatin C IVD kit rapid fluorescent immunoassay clinical | Cystatin C IVD kit rapid fluorescent immunoassay clinical | IVD General
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| Glucose analyser IVD home-use | Glucose analyser IVD home-use | IVD Annex II List B
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| Glucose monitoring system IVD home-use | Glucose monitoring system IVD home-use | IVD Annex II List B
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| Glucose IVD reagent | Glucose IVD reagent | IVD Annex II List B
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| Glucose IVD control | Glucose IVD control | IVD Annex II List B
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| Free (unbound) prostate specific antigen (fPSA) IVD kit rapid ICT clinical | Free (unbound) prostate specific antigen (fPSA) IVD kit rapid ICT clinical | IVD Annex II List B
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| Neisseria gonorrhoeae antigen IVD kit rapid ICT clinical | Neisseria gonorrhoeae antigen IVD kit rapid ICT clinical | IVD General
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| Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical | Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical | IVD General
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| Faecal occult blood IVD kit rapid ICT self-testing | Faecal occult blood IVD kit rapid ICT self-testing | IVD Devices for Self-Testing
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| HIV1/HIV2 antibody IVD kit rapid ICT clinical | HIV1/HIV2 antibody IVD kit rapid ICT clinical | IVD Annex II List A
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| Influenza A/B virus antigen IVD kit rapid ICT clinical | Influenza A/B virus antigen IVD kit rapid ICT clinical | IVD Devices for Self-Testing
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| Myoglobin IVD kit fluorescent immunoassay | Myoglobin IVD kit fluorescent immunoassay | IVD Devices for Self-Testing
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| D-dimer IVD kit fluorescent immunoassay | D-dimer IVD kit fluorescent immunoassay | IVD General
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| Troponin I IVD kit fluorescent immunoassay | Troponin I IVD kit fluorescent immunoassay | IVD General
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| B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassay | B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassay | IVD General
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| Sperm concentration indicator IVD kit rapid ICT self-testing | Sperm concentration indicator IVD kit rapid ICT self-testing | IVD General
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| Fluorescent spectrophotometer IVD | Fluorescent spectrophotometer IVD | IVD Devices for Self-Testing
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| Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical | Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical | IVD General
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| Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid | Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid | IVD Annex II List B
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| Follicle stimulating hormone (FSH) IVD kit immunochromatographic test (ICT) rapid professional/self-test | Follicle stimulating hormone (FSH) IVD kit immunochromatographic test (ICT) rapid professional/self-test | IVD Devices for Self-Testing
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| Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | IVD General
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| C-reactive protein (CRP) IVD kit fluorescent immunoassay | C-reactive protein (CRP) IVD kit fluorescent immunoassay | IVD Devices for Self-Testing
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| Fatty acid binding protein (FABP) IVD kit chemiluminescent immunoassay | Fatty acid binding protein (FABP) IVD kit chemiluminescent immunoassay | IVD General
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| Interleukin-6 (IL-6) IVD kit rapid ICT clinical | Interleukin-6 (IL-6) IVD kit rapid ICT clinical | IVD General
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| Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical | Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical | IVD General
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| Ketamine/ketamine metabolite IVD kit rapid ICT clinical | Ketamine/ketamine metabolite IVD kit rapid ICT clinical | IVD General
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| Glycated haemoglobin (HbA1c) IVD kit rapid ICT clinical | Glycated haemoglobin (HbA1c) IVD kit rapid ICT clinical | IVD Annex II List B
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| Alpha-fetoprotein (AFP) IVD kit fluorescent immunoassay | Alpha-fetoprotein (AFP) IVD kit fluorescent immunoassay | IVD General
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| Amphetamine/methamphetamine group IVD kit rapid ICT clinical | Amphetamine/methamphetamine group IVD kit rapid ICT clinical | Class C – Self-testing or Near-patient Testing
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| Methamphetamine-specific IVD kit rapid ICT clinical | Methamphetamine-specific IVD kit rapid ICT clinical | Class C – Self-testing or Near-patient Testing
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| Barbiturate IVD kit enzyme immunoassay (EIA) | Barbiturate IVD kit enzyme immunoassay (EIA) | Class A
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| Benzodiazepine group IVD kit enzyme immunoassay (EIA) | Benzodiazepine group IVD kit enzyme immunoassay (EIA) | IVD General
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| Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA) | Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA) | IVD General
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| Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA) | Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA) | IVD General
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| Fentanyl IVD reagent | Fentanyl IVD reagent | IVD General
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| Morphine/morphine metabolite IVD kit rapid ICT clinical | Morphine/morphine metabolite IVD kit rapid ICT clinical | IVD General
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| Activated partial thromboplastin time (APTT) IVD reagent | Activated partial thromboplastin time (APTT) IVD reagent | IVD General
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| Complexed prostate specific antigen (cPSA) IVD control | Complexed prostate specific antigen (cPSA) IVD control | IVD General
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| Carcinoembryonic antigen (CEA) IVD control | Carcinoembryonic antigen (CEA) IVD control | IVD General
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| Carcinoembryonic antigen (CEA) IVD kit fluorescent immunoassay | Carcinoembryonic antigen (CEA) IVD kit fluorescent immunoassay | IVD General
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| Alpha-fetoprotein (AFP) IVD control | Alpha-fetoprotein (AFP) IVD control | IVD General
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| Total cortisol IVD control | Total cortisol IVD control | IVD Annex II List B
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| Estradiol (oestradiol) (E2) IVD reagent | Estradiol (oestradiol) (E2) IVD reagent | IVD General
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| Follicle stimulating hormone (FSH) IVD reagent | Follicle stimulating hormone (FSH) IVD reagent | IVD General
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| Luteinizing hormone (LH) IVD kit rapid ICT clinical | Luteinizing hormone (LH) IVD kit rapid ICT clinical | IVD General
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| Procalcitonin (PCT) IVD kit fluorescent immunoassay | Procalcitonin (PCT) IVD kit fluorescent immunoassay | IVD General
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| Procalcitonin (PCT) IVD control | Procalcitonin (PCT) IVD control | IVD General
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| Progesterone IVD kit enzyme immunoassay (EIA) | Progesterone IVD kit enzyme immunoassay (EIA) | IVD General
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| Multiple form 25-hydroxy Vitamin D IVD control | Multiple form 25-hydroxy Vitamin D IVD control | IVD General
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| Multiple urine analyte IVD kit rapid colorimetric clinical | Multiple urine analyte IVD kit rapid colorimetric clinical | IVD General
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| Thrombin time (TT) IVD reagent | Thrombin time (TT) IVD reagent | IVD General
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| Activated clotting time (ACT) IVD reagent | Activated clotting time (ACT) IVD reagent | IVD General
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| Free thyroxine (FT4) IVD kit fluorescent immunoassay | Free thyroxine (FT4) IVD kit fluorescent immunoassay | IVD General
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| Total thyroxine (TT4) IVD kit fluorescent immunoassay | Total thyroxine (TT4) IVD kit fluorescent immunoassay | IVD General
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| Total triiodothyronine (TT3) IVD kit fluorescent immunoassay | Total triiodothyronine (TT3) IVD kit fluorescent immunoassay | IVD General
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| General specimen container IVD additive/medium | General specimen container IVD additive/medium | IVD General
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| Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | IVD General
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| Tramadol IVD kit rapid ICT clinical | Tramadol IVD kit rapid ICT clinical | IVD General
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| Free triiodothyronine (FT3) IVD kit rapid ICT clinical | Free triiodothyronine (FT3) IVD kit rapid ICT clinical | IVD General
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| SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical | IVD General
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| Microplate/tube/assay card incubator IVD | Microplate/tube/assay card incubator IVD | IVD General
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| Anti-Mullerian hormone (AMH) IVD kit rapid ICT clinical | Anti-Mullerian hormone (AMH) IVD kit rapid ICT clinical | IVD General
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| Dengue virus antigen IVD kit rapid ICT clinical | Dengue virus antigen IVD kit rapid ICT clinical | IVD General
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| Dengue virus antigen/antibody IVD kit rapid ICT clinical | Dengue virus antigen/antibody IVD kit rapid ICT clinical | IVD General
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| Propoxyphene/propoxyphene metabolite IVD kit rapid ICT clinical | Propoxyphene/propoxyphene metabolite IVD kit rapid ICT clinical | IVD General
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| Fibrinogen assay (factor I) IVD reagent | Fibrinogen assay (factor I) IVD reagent | IVD General
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| Total testosterone IVD kit enzyme immunoassay (EIA) | Total testosterone IVD kit enzyme immunoassay (EIA) | IVD General
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| Prolactin IVD kit fluorescent immunoassay | Prolactin IVD kit fluorescent immunoassay | IVD General
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| Ferritin IVD kit fluorescent immunoassay | Ferritin IVD kit fluorescent immunoassay | IVD General
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| 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA) | 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA) | IVD General
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| Allergen-specific/total immunoglobulin E (IgE) antibody IVD kit fluorescent immunoassay | Allergen-specific/total immunoglobulin E (IgE) antibody IVD kit fluorescent immunoassay | IVD General
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| Microalbumin IVD kit rapid ICT clinical | Microalbumin IVD kit rapid ICT clinical | IVD General
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| Ethyl glucuronide (EtG) IVD reagent | Ethyl glucuronide (EtG) IVD reagent | IVD General
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| Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassay | Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassay | IVD General
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| Multi-modality clinical specimen analysis system IVD | Multi-modality clinical specimen analysis system IVD | IVD General
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| Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical | Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical | IVD General
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| Cannabinoid/cannabinoid metabolite IVD kit rapid ICT clinical | Cannabinoid/cannabinoid metabolite IVD kit rapid ICT clinical | IVD General
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| Troponin I IVD kit rapid ICT clinical | Troponin I IVD kit rapid ICT clinical | IVD General
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| Multiple cardiac marker IVD control | Multiple cardiac marker IVD control | IVD General
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| D-dimer IVD control | D-dimer IVD control | IVD General
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| B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD control | B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD control | IVD General
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| Multiple cardiac marker IVD kit fluorescent immunoassay | Multiple cardiac marker IVD kit fluorescent immunoassay | IVD General
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| Neutrophil gelatinase-associated lipocalin (NGAL) IVD kit fluorescent immunoassay | Neutrophil gelatinase-associated lipocalin (NGAL) IVD kit fluorescent immunoassay | IVD General
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| Thermal cycler nucleic acid amplification analyser IVD laboratory | Thermal cycler nucleic acid amplification analyser IVD laboratory | IVD General
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| Cystatin C IVD control | Cystatin C IVD control | IVD General
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| Multiple gastrointestinal virus antigen IVD kit rapid ICT clinical | Multiple gastrointestinal virus antigen IVD kit rapid ICT clinical | IVD General
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| Hepatitis A virus immunoglobulin M (IgM) antibody IVD reagent | Hepatitis A virus immunoglobulin M (IgM) antibody IVD reagent | IVD General
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| Creatine kinase myocardial isoenzyme (CKMB) IVD control | Creatine kinase myocardial isoenzyme (CKMB) IVD control | IVD General
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| Glycated haemoglobin (HbA1c) IVD control | Glycated haemoglobin (HbA1c) IVD control | IVD General
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| Human chorionic gonadotropin beta-core fragment IVD control | Human chorionic gonadotropin beta-core fragment IVD control | IVD General
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| Methadone IVD kit rapid ICT clinical | Methadone IVD kit rapid ICT clinical | IVD General
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| Phencyclidine (PCP) IVD kit rapid ICT clinical | Phencyclidine (PCP) IVD kit rapid ICT clinical | IVD General
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| Tricyclic antidepressant IVD kit rapid ICT clinical | Tricyclic antidepressant IVD kit rapid ICT clinical | IVD General
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| Opiate/opiate metabolite IVD kit rapid ICT clinical | Opiate/opiate metabolite IVD kit rapid ICT clinical | IVD General
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| Multiple coagulation factor IVD control | Multiple coagulation factor IVD control | IVD General
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| Myoglobin IVD control | Myoglobin IVD control | IVD General
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| Fatty acid binding protein (FABP) IVD control | Fatty acid binding protein (FABP) IVD control | IVD General
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| Human chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinical | Human chorionic gonadotropin beta-core fragment IVD kit rapid ICT clinical | IVD General
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| Hepatitis E virus immunoglobulin M (IgM) antibody IVD reagent | Hepatitis E virus immunoglobulin M (IgM) antibody IVD reagent | IVD General
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| Enterovirus immunoglobulin M (IgM) antibody (serotypes 68-71) IVD reagent | Enterovirus immunoglobulin M (IgM) antibody (serotypes 68-71) IVD reagent | IVD General
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| Nucleic acid extraction/isolation kit IVD | Nucleic acid extraction/isolation kit IVD | IVD General
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| Multiple blood gas/haemoximetry/electrolyte analyte IVD kit multiple technologies | Multiple blood gas/haemoximetry/electrolyte analyte IVD kit multiple technologies | IVD General
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| Multiple blood gas/haemoximetry/electrolyte analyte IVD calibrator | Multiple blood gas/haemoximetry/electrolyte analyte IVD calibrator | IVD General
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| Multiple blood gas/haemoximetry/electrolyte analyte IVD control | Multiple blood gas/haemoximetry/electrolyte analyte IVD control | IVD General
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| Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent | Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent | IVD General
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| Serum amyloid A IVD kit enzyme immunoassay (EIA) | Serum amyloid A IVD kit enzyme immunoassay (EIA) | IVD General
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| Microalbumin IVD control | Microalbumin IVD control | IVD General
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| Beta-2-microglobulin IVD kit enzyme immunoassay (EIA) | Beta-2-microglobulin IVD kit enzyme immunoassay (EIA) | IVD General
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| Troponin T IVD kit fluorescent immunoassay | Troponin T IVD kit fluorescent immunoassay | IVD General
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| Troponin I IVD control | Troponin I IVD control | IVD General
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| Plasmodium falciparum antigen IVD reagent | Plasmodium falciparum antigen IVD reagent | IVD General
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| Plasmodium falciparum antigen IVD kit rapid ICT clinical | Plasmodium falciparum antigen IVD kit rapid ICT clinical | IVD General
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| Multiple Plasmodium species antigen IVD kit rapid ICT clinical | Multiple Plasmodium species antigen IVD kit rapid ICT clinical | IVD General
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| Dengue virus antigen IVD reagent | Dengue virus antigen IVD reagent | IVD General
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| Influenza A virus antigen IVD kit rapid ICT clinical | Influenza A virus antigen IVD kit rapid ICT clinical | IVD General
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| Influenza B virus antigen IVD kit rapid ICT clinical | Influenza B virus antigen IVD kit rapid ICT clinical | IVD General
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| Adenovirus antigen IVD kit rapid ICT clinical | Adenovirus antigen IVD kit rapid ICT clinical | IVD General
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| Rotavirus antigen IVD kit rapid ICT clinical | Rotavirus antigen IVD kit rapid ICT clinical | IVD General
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| Chlamydia trachomatis antigen IVD reagent | Chlamydia trachomatis antigen IVD reagent | IVD General
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| Helicobacter pylori total antibody IVD reagent | Helicobacter pylori total antibody IVD reagent | IVD Devices for Self-Testing
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| Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit fluorescent immunoassay | Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit fluorescent immunoassay | IVD General
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| Multiple human hormone IVD control | Multiple human hormone IVD control | IVD Devices for Self-Testing
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| Faecal occult blood IVD kit rapid ICT clinical | Faecal occult blood IVD kit rapid ICT clinical | IVD General
|
| Total cortisol IVD kit rapid ICT clinical | Total cortisol IVD kit rapid ICT clinical | IVD General
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| Coagulation analyser IVD point-of-care line-powered | Coagulation analyser IVD point-of-care line-powered | IVD Annex II List B
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| Multiple drugs of abuse IVD kit rapid ICT clinical | Multiple drugs of abuse IVD kit rapid ICT clinical | IVD General
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| Ethanol (ETOH) IVD kit rapid enzyme spectrophotometry clinical | Ethanol (ETOH) IVD kit rapid enzyme spectrophotometry clinical | IVD General
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| C-reactive protein (CRP) IVD control | C-reactive protein (CRP) IVD control | IVD General
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| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
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| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
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| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | Class A
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| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | Class A
|
| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
|
| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD Devices for Self-Testing
|
| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | Class A
|
| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
|
| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
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| Prothrombin time (PT) IVD reagent | Prothrombin time (PT) IVD reagent | IVD General
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