M/S. MEDSOURCE OZONE BIOMEDICALS PVT LTD
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 114 |
| Class B | Low–moderate risk | 738 |
| Class C | Moderate–high risk | 75 |
| Class D (high risk) | Highest-risk devices | 40 |
CDSCO device licences
Used for the automated pre-analytical preparation of a clinical specimen which may include the sampling, diluting, and/or aliquot ting of clinical specimens. The instrument is intended for use in medical and biological laboratories by profe…
MFG/IVD/2020/000001 · HaryanaGlycosylated Hemoglobin Test Reagents/Kits is a turbidimetric assay for the quantitative determination of the percentage of glycosylated haemoglobin (HbA1c) levels in human whole blood. HbA1c measurement is also used in the screening and mo…
MFG/IVD/2020/000001 · HaryanaImmunoturbidimetric reagent for the quantitative determination of D-Dimer concentration in human plasma on Coagulometer.
MFG/IVD/2019/000057An instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques.
MFG/IVD/2020/000001 · HaryanaThe Hematology Control is a quality control material intended for use in conjugation with 5-part differential hematology analyzers to monitor, verify and maintain analyzer performance and precision by providing assigned target values for co…
MFG/IVD/2020/000001 · HaryanaIt is designed to quantitatively measure the concentration of glucose in capillary whole blood by people with diabetes or by healthcare professionals for monitoring Blood Glucose at home or in healthcare facilities.
MFG/IVD/2019/000057HIV Ag/Ab combo rapid test is an immunoassay for qualitative and differential detection of antibodies of all subtypes (IgG, IgM & IgA) specific to HIV-1 & 2 and p24 antigen of HIV in human serum, plasma and whole blood as a screening test i…
MFG/IVD/2019/000057This card is used for bed side confirmation of the human Blood group i.e. A, B, AB and O including Rh factor. The test is a tool to reconfirm an earlier known ABO- and D-blood type for a patient just before transfusion. The test is not to …
MFG/IVD/2019/000057H.pylori Antibody test reagent/kit is a reagents and kits medical device intended for the detection of H.pylori Antibody in blood/body fluids
MFG/IVD/2020/000001 · HaryanaA blood cell diluent is a medical device used to dilute blood for further testing , such as complete blood count (CBC)
MFG/IVD/2020/000001 · HaryanaPregnancy rapid test device (Serum/Plasma/Whole Blood) is a lateral flow immunochromatographic assay for the qualitative detection of concentration of Pregnancy-Associated Glycoproteins (PAG) in Cattle/Goat/Sheep serum, plasma and whole blo…
MFG/IVD/2020/000001 · HaryanaA human chorionic gonadotropin ( hCG ) test reagent/kit is a medical device intended for the preliminary self testing of hCG in urine
MFG/IVD/2020/000001 · HaryanaAnti nuclear Antibodies test reagent /kit is a me medical device for the screening of auto of CCP auto antibodies to nuclear antigens in human specimens
MFG/IVD/2020/000001 · HaryanaMalaria Pf/Pv Antigen is an immunochromatographic assay for the detection and differentiation of Plasmodium falciparum and Plasmodium vivax in human whole blood.
MFG/IVD/2019/000057Troponin I is an immunochromatographic assay for the detection of cardiac Troponin I (cTnI) and its complex in human serum, plasma or whole blood.
MFG/IVD/2019/000057Malaria Pf/Pan Antigen is an immunochromatographic assay for the detection and differentiation of Plasmodium falciparum and/or Plasmodium vivax, Plasmodium ovale and Plasmodium malariae antigen in human whole blood
MFG/IVD/2019/000057Malaria PAN Antigen test is an immunochromatographic assay for detection of Plasmodium falciparum, plasmodium vivax, plasmodium ovale and plasmodium malariae in human whole blood
MFG/IVD/2019/000057TOXOPLASMA IgG/IgM is an immunochromatographic assay used for detection for IgG and IgM antibodies to Toxoplasma gondii in human Serum/Plasma
MFG/IVD/2019/000057DENGUE NS1 Antigen ELISA assay is used for in vitro qualitative detection of Dengue NS1 antigen in human serum or plasma .
MFG/IVD/2019/000057RUBELLA IgG/IgM is an immunochromatographic assay used for detection for IgG and IgM antibodies to RUBELLA virus in human Serum/Plasma
MFG/IVD/2019/000057Dengue NS1 Rapid test kit is an immunochromatographic assay used for detection for Dengue NS1 Antigen in human Serum/Plasma/Whole blood.
MFG/IVD/2019/000057PT (Thromboplastin time) assay kit is used for determination of Prothrombin time in human Plasma.
MFG/IVD/2019/000057The Dengue Combo Rapid test kit is an immunochromatographic assay used for detection for Dengue NS1 Antigen and IgG/IgM antibodies specific to Dengue in human specimen.
MFG/IVD/2019/000057RPR test kit is used for Qualitative and semi quantitative detection for reagin antibodies in human serum.
MFG/IVD/2019/000057Malaria PF Antigen test is an immunochromatographic assay for detection of Plasmodium falciparum in human whole blood
MFG/IVD/2019/000057The H. pylori Antigen is an immunochromatographic assay for detection of H. pylori (Helicobacter pylori) Antigen in human feces.
MFG/IVD/2019/000057Typhoid Antigen Test is an immunochromatographic assay for the detection of S.typhi and Paratyphi antigens in human specimen.
MFG/IVD/2019/000057aPTT (activated partial Thromboplastin time) assay kit is used for determination of activated partial thromboplastin time in human Plasma
MFG/IVD/2019/000057HIV & Syphilis Combo Rapid Test is a qualitative test based on the principle of immuno-chromatography for simultaneous and differential detection of HIV 1 & 2 and Syphilis/TP antibodies in human serum/ plasma/ whole blood as in aid for diag…
MFG/IVD/2019/000057An instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen
MFG/IVD/2020/000001 · HaryanaN-Terminal Pro-brain Natriuretic Peptide (POCT) Kit is a fluorescence immunoassay (FIA) for the quantitative determination of NT-Pro BNP in Human serum, plasma and whole Blood.
MFG/IVD/2019/000057HCV ELISA kit is an enzyme immunoassay intended used for the qualitative detection of antibodies of HCV (Hepatitis C virus) in human serum or plasma. It is a screening test for the detection of antibodies as an aid in the diagnosis of infec…
MFG/IVD/2019/000057HBsAg ELISA kit is an enzyme immunoassay intended used for the qualitative detection of HBsAg (Hepatitis B Surface Antigen) in human serum or plasma. It is a screening test for the detection of HBsAg as an aid in the diagnosis of infection …
MFG/IVD/2019/000057Troponin I (POCT) Kit is a fluorescence immunoassay (FIA) for the quantitative determination of cardiac troponin I in human serum, plasma and whole blood.
MFG/IVD/2019/000057HIV 1&2 ELISA kit is a 3rd generation enzyme immuno assay intended used for the qualitative detection of antibodies to HIV-1 and HIV-2 in human serum or plasma. It is a screening test for the detection of antibodies as an aid in the diagnos…
MFG/IVD/2019/000057The hCG is a rapid immunochromatographic assay for the qualitative detection of hCG (human chorionic gonadotropin) in urine to aid in early diagnosis of pregnancy.
MFG/IVD/2020/000001 · HaryanaIron-Binding Capacity reagent kit is a photometric assay for the quantitative determination of unsaturated iron-binding capacity (UIBC) in human serum and plasma. UIBC measurement is also used in screening, diagnosis, and monitoring of iron…
MFG/IVD/2020/000001 · HaryanaA Lyse reagent/kit is a medical device used for lysing of cells for the estimation of Complete Blood Count(CBC).
MFG/IVD/2020/000001 · HaryanaThe Hemotology Solution 3-part WBC differential haematology systems use impedance method for cell counting. The haemoglobin concentration is measured by photometric method (540nm). The SOLUTION is used to measure 22 parameters, providing a …
MFG/IVD/2020/000001 · HaryanaThe DNA/RNA Extraction kit is used for preparation of purified viral DNA/RNA from VTM/VLTM specimen. The DNA/RNA Extraction Kit is intended to be used only in combination with Automated Nucleic Acid Extraction System ? Genepure Pro NPA-32P.
MFG/IVD/2019/000057An instrument designed and constructed for accurate and precise liquid handling, specifically intended by the manufacturer to be used for in vitro diagnostic examinations/procedures. It is intended to dispense liquid (sample/specimen/buffer…
MFG/IVD/2020/000001 · HaryanaHIV 1/2 Rapid Test is an immunochromatographic assay used for detection of antibodies specific to HIV-1 and HIV-2 in human Specimen
MFG/IVD/2019/000057The monoclonal blood grouping reagent is used for detection of Rh D antigens in blood by agglutination of human red blood cells.
MFG/IVD/2019/000057HCV Ag/Ab ELISA kit is used for the qualitative detection of HCV core antigen and antibodies of hepatitis C virus (HCV) in human serum or plasma as an aid in the diagnosis of infection with HCV. For professional and in-vitro diagnostic use …
MFG/IVD/2019/000057Syphilis rapid test is an immunochromatographic assay used for detection of antibodies (IgG & IgM) to Treponema pallidum (TP) in human specimen
MFG/IVD/2019/000057The monoclonal blood grouping reagent is used for detection of ?B? antigens in blood by agglutination of human red blood cells.
MFG/IVD/2019/000057Syphilis strip is a rapid immunochromatographic assay used for detection of antibodies (IgG & IgM) to Treponema pallidum (TP) in human specimen.
MFG/IVD/2019/000057HCV Rapid test is an immunochromatographic assay used for detection for HCV antibodies in human Specimen
MFG/IVD/2019/000057HBsAg Rapid test kit is an immunochromatographic assay used for detection for Hepatitis B surface antigen in human Specimen.
MFG/IVD/2019/000057The monoclonal blood grouping reagent is used for detection of Rh D antigens in blood by agglutination of human red blood cells.
MFG/IVD/2019/000057Global footprint
Cross-railThe same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.
No FDA clearances linked — India-domestic footprint.
Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.