M/s.Avantor Performance Materials India Ltd
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 17 |
| Class B | Low–moderate risk | 588 |
| Class C | Moderate–high risk | 79 |
| Class D (high risk) | Highest-risk devices | 32 |
CDSCO device licences
HBV Rapid Card is an in vitro, qualitative, one step immunochromatographic test for the detection of Hepatitis B surface Antigen in human serum, plasma and whole blood.
MFG/IVD/2023/000133HBV Rapid Card is an in vitro, qualitative, one step immunochromatographic test for the detection of Hepatitis B surface Antigen in human serum, plasma and whole blood.
MFG/IVD/2023/000133Diatro Dil-5P diluent is a buffered, stabilized and micro-filtered electrolyte solution for automated dilution of human samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC), and the leucocytes subpopul…
MFG/IVD/2023/000046 · UttarakhandDiatro Dil-Diff diluent is a buffered, stabilized and micro-filtered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC), and the leucocytes …
MFG/IVD/2023/000046 · UttarakhandUsed in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.
IMP/IVD/2022/000256 · from ChinaThe 3 Hematology Scan system is a quantitative multi-parameter automated hematology analyzer for in-vitro-diagnostic use, for measuring complete blood count and leukocytes 3 part differential in K2 or K3-EDTA anti-coagulated venous human wh…
IMP/IVD/2025/000044 · from HungaryThe 5 Hematology Scope system is a quantitative multi-parameter automated hematology analyzer for in-vitro-diagnostic use, for measuring complete blood count and leukocytes 5 part differential in K2 or K3-EDTA anti-coagulated venous human w…
IMP/IVD/2025/000044 · from HungaryBeneSphera Malaria PAN/Pf 2.0 antigen rapid card test is a quick immuno-chromatographic qualitative test for the distinct diagnosis of PAN malaria specific LDH and P. falciparum specific HRP-II, allowing it to detect Pan and Pf distinctly. …
MFG/IVD/2023/000133BeneSphera Syphilis Antibody 2.0 Rapid Card is a visual immunochromatographic, qualitative, screening test for the detection of antibodies to Treponema pallidum (Tp) in fresh human serum and plasma samples for the diagnosis of Syphilis Infe…
MFG/IVD/2023/000133BeneSphera?HIV 1/2 Antibody 3.0 Rapid Card Test is a 3rd generation solid phase immunochromatographic assay for the rapid, qualitative and differential detection of antibodies (IgG, IgM, IgA) to HIV-1 including subgroup 'O' and HIV-2 in ser…
MFG/IVD/2023/000133BeneSphera? HIV 1/2 Antibody 3.0 Rapid Card Test is a 3rd generation solid phase immunochromatographic assay for the rapid, qualitative and differential detection of antibodies (IgG, IgM, IgA) to HIV-1 including subgroup 'O' and HIV-2 in se…
MFG/IVD/2023/000133BeneSphera?Syphilis Antibody rapid card test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of antibodies to Treponema pallidum in human serum or Plasma. This test is intended for professi…
MFG/IVD/2023/000133BeneSpheraTM Malaria P.v./P.f. Rapid Card Test is a rapid, selfperforming, qualitative, two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 (P.f HRP-2) and P.vivax specifi…
MFG/IVD/2023/000133BeneSphera? Syphilis Antibody rapid card test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of antibodies to Treponema pallidum in human serum or Plasma. This test is intended for profess…
MFG/IVD/2023/000133BeneSphera Syphilis Antibody 2.0 Rapid Card is a visual immunochromatographic, qualitative, screening test for the detection of antibodies to Treponema pallidum (Tp) in fresh human serum and plasma samples for the diagnosis of Syphilis Infe…
MFG/IVD/2023/000133BeneSphera SyphDip 2.0 Rapid (Dipstick) is a visual immunochromatographic, qualitative, screening test for the detection of antibodies to Treponema pallidum (Tp) in fresh human serum, plasma or whole blood samples for the diagnosis of Syphi…
MFG/IVD/2023/000133BeneSphera SyphDip 2.0 Rapid (Dipstick) is a visual immunochromatographic, qualitative, screening test for the detection of antibodies to Treponema pallidum (Tp) in fresh human serum, plasma or whole blood samples for the diagnosis of Syphi…
MFG/IVD/2023/000133BeneSphera Malaria PAN/Pf 2.0 antigen rapid card test is a quick immuno-chromatographic qualitative test for the distinct diagnosis of PAN malaria specific LDH and P. falciparum specific HRP-II, allowing it to detect Pan and Pf distinctly. …
MFG/IVD/2023/000133BeneSpheraTM Malaria P.v./P.f. Rapid Card Test is a rapid, selfperforming, qualitative, two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 (P.f HRP-2) and P.vivax specifi…
MFG/IVD/2023/000133Reagent that helps to dilute the whole-blood sample and provide the conductive environment for the enumeration of leukocytes (white blood cells) and the derivation of leukocyte subpopulations i.e., Lysing & counting. The diluent provides th…
MFG/IVD/2023/000046 · UttarakhandReagent that helps to dilute the whole-blood sample and provide the conductive environment for the enumeration of leukocytes (white blood cells) and the derivation of leukocyte subpopulations i.e., Lysing & counting. The diluent provides th…
MFG/IVD/2023/000046 · UttarakhandUsed Quantitative Determination of Free Thyroxine in Human Serum
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Follicle Stimulating Hormone in Human Serum.
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Free Triiodothyronine in Human Serum
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Luteinizing Hormone in Human Serum
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of TSH in Human Serum
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Prolactin in Human Serum
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Total Triiodothyronine in Human
IMP/IVD/2024/000143 · from United StatesUsed Quantitative Determination of Total Thyroxine in Human Serum
IMP/IVD/2024/000143 · from United StatesQuantitative determination of total 25(OH) D2/D3 level in human serum/plasma. The test is used as an aid in management and monitoring of regulating the concentration of calcium and phosphate in the bloodstream and promoting the health growt…
IMP/IVD/2024/000080 · from ChinaQuantitative determination of Thyroid Stimulating Hormone (TSH) in human serum, plasma or whole blood. The test is used as an aid to assist in the assessment of pituitary gland and thyroid function.
IMP/IVD/2024/000080 · from ChinaQuantitative determination of Triiodothyronine (total T3) in human serum, plasma or whole blood. The test is used as an aid to the assessment of thyroid function.
IMP/IVD/2024/000080 · from ChinaThe Prolactin Rapid Quantitative Test is a fluorescence immunoassay used along with FIA Meters (Model No.: FS-112, FS-113, FS-114, FS-205) for quantitative measurement of Prolactin (PRL) in human whole blood, serum or plasma. The test is us…
IMP/IVD/2024/000080 · from ChinaQuantitative determination of Thyroxine (Total T4) in human serum, plasma or whole blood. The test is used as an aid to the assessment of thyroid function.
IMP/IVD/2024/000080 · from ChinaQuantitative determination of PCT in human whole blood, serum or plasma. This test is used as an aid to diagnosis severe, bacterial infection and sepsis.
IMP/IVD/2024/000080 · from ChinaQuantitative determination of NT-proBNP in human whole blood, serum or plasma. The test is used as an aid for the diagnosis of suspected congestive heart failure. "
IMP/IVD/2024/000080 · from ChinaQuantitative determination of MAU in human urine. This test is used as an aid to diagnosis of kidney damage."
IMP/IVD/2024/000080 · from ChinaIntended for quantitative determination of Progesterone in human serum, whole blood or plasma.
IMP/IVD/2024/000080 · from ChinaTestosterone Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareTM FIA Meters (Model No.: FS-112, FS-113, FS-114 and FS-205) for quantitative measurement of Testosterone in human whole blood, serum or plasma. The …
IMP/IVD/2024/000080 · from ChinaQuantitative determination of H-FABP in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction.
IMP/IVD/2024/000080 · from ChinaQuantitative determination of D-Dimer in human whole blood and plasma. This test is used as an aid to assist in the diagnosis of thrombosis and thrombotic diseases."
IMP/IVD/2024/000080 · from ChinaQuantitative determination of cTn I in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of acute myocardial infarction (AMI).
IMP/IVD/2024/000080 · from ChinaThe Estradiol (E2) Rapid Quantitative Test is a fluorescence immunoassay used along with FIA Meters (Model No.: FS-112, FS-113, FS-114, FS-205) is for quantitative measurement of Estradiol (E2) in human whole blood, serum or plasma. The tes…
IMP/IVD/2024/000080 · from ChinaIntended for quantitative determination of Luteinizing hormone (LH) in human whole blood or plasma.
IMP/IVD/2024/000080 · from ChinaIntended for quantitative measurement of Follicle-stimulating hormone (FSH) in human whole blood or plasma.
IMP/IVD/2024/000080 · from ChinaUsed Quantitative determination of Hemoglobin A1c in human blood. The test is used as an aid to monitor long-term glycemic status in patients with diabetes mellitus.
IMP/IVD/2024/000080 · from Chinaquantitative determination of CRP and PCT in human whole blood, serum or plasma. This test is used as an aid to see infection and inflammation and used to aid in the early detection of clinically relevant bacterial infections."
IMP/IVD/2024/000080 · from China"Quantitative analysis of cross-linked fibrin degradation products containing D- Dimer in human whole blood or plasma. The test is used as an aid in detecting the presence and assessing the degree of intravascular coagulation or thromboembo…
IMP/IVD/2024/000080 · from China"Quantitative measurement of procalcitonin in human whole blood, serum or plasma. The test is used as an aid to diagnose and control the treatment of severe, bacterial infection and sepsis."
IMP/IVD/2024/000080 · from ChinaQuantitative determination of CK-MB in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of acute myocardial infarction (AMI).
IMP/IVD/2024/000080 · from ChinaGlobal 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.