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Essential in vitro Diagnostics (EDL)
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Type of medical device or related product: In vitro diagnostic tests
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WHO lists of priority medical devices
Particular indications (ICD-11)
Various conditions or disease specific
Organ or system related according to ICD-11
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Interventions (non-exhaustive list)
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Type of medical device
Capital, reusable or single-use
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Consumable
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Amplification Kit for IHC staining platform
Antibody detection kit for IHC staining platform
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Blood glucose meter
Blood ketone meter
Cryptococcal antigen test RDT
Dipstick, analyser
Enzyme Immuno Assay (EIA), gonorrhea Ag, kit
Enzyme Immuno Assay (EIA), Human Immunodeficiency Virus (HIV), kit
Haemoglobin colour scale
Haemoglobin colour scale, refill kit
Haemoglobin colour scale, starter kit
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Hepatitis B virus e-antigen IVD, kit, enzyme immunoassay (EIA)
Hepatitis B virus e-antigen IVD, kit, rapid ICT, clinical
Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA)
Hepatitis C virus core antigen IVD, kit, enzyme immunoassay (EIA)
Hepatitis C virus total antibody IVD, kit, enzyme immunoassay (EIA)
HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical
Influenza A/B virus antigen IVD, kit, enzyme immunoassay (EIA)
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Kato-Katz, kit, stool sample preparation
Primary antibodies
Rapid Diagnostic Immunodeficiency Virus (HIV), kit
Rapid Plasma Reagin (RPR), syphilis, kit
Sugar fermentation tests
Test strip, pregnancy
Test strip, vaginal infection, pH
Test, drug susceptibility
Test, Faecal Occult Blood test (FOBT), rapid, kit
Test, haemoglobin estimation, rapid
Test, HBsAg, rapid
Test, HCV, rapid
Test, HIV 1 & 2, rapid
Test, HPV DNA
Test, latex agglutination, meningitis
Test, malaria, Rapid Diagnostic Test (RDT), kit
Test, Nickerson or Sabouraud medium, kit
Test, Nucleic Acid Amplification Test (NAAT), Chlamydia, kit
Test, Nucleic Acid Amplification Test (NAAT), gonorrhea, kit
Test, Nucleic Acid Test (NAT), Human Papilloma Virus (HPV), kit
Test, oxidase
Test, potassium hydroxide KOH, preparation
Test, RPR (Rapid Plasma Reagin)
Test, Treponemal, Rapid Diagnostic Test (RDT), kit
Treponema Pallidum Haemagglutination Assay (TPHA)
Urine color scale guide