Sysmex India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 68 |
| Class B | Low–moderate risk | 340 |
| Class C | Moderate–high risk | 109 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
UFII Pack-SED dilutes the aspirated sample so that erythrocytes, leukocytes, epithelial cells, and casts can be measures by flow cytometry method.
IMP/IVD/2019/000157 · from SingaporeDiluent Sysmex pocH- pack D(II) for the pocH-100i automated hematology analyzer
IMP/IVD/2019/000157 · from SingaporeSysmex pocH pack L (II) is a reagent that lyses RBC for accurate WBC count determination, WBC trimodal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compou…
IMP/IVD/2019/000157 · from SingaporeUXII Pack-SED dilutes the aspirated material so that erythrocytes, leukocytes, epithelial cells, and casts can be measured by flow cytometry method
IMP/IVD/2019/000157 · from JapanSULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers
IMP/IVD/2019/000157 · from SingaporeFor in vitro diagnostic use only CELLPACK DFL is a reagent used in combination with Fluorocell RET. After diluting the blood with CELLPACK DFL, Fluorocell RET is used to label blood cell components and thereby analyze red blood cell count, …
IMP/IVD/2019/000157 · from JapanThe STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count and WBC count with Sysmex automated hematology analyzers (on XS-series only)
IMP/IVD/2019/000157 · from SingaporeThe UFII SHEATH is the sheath fluid used in order to analyze the diluted and stained samples by flow cytometry method.
IMP/IVD/2019/000157 · from JapanFor in vitro diagnostic use only UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cyt…
IMP/IVD/2019/000157 · from SingaporeSTROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of 4-part differential count, or 5-part differential count and WBC count with Sysmex automated hematology analyzers (on XS series o…
IMP/IVD/2019/000157 · from JapanThe UXII SHEATH is the sheath fluid used in order to analyze the diluted and stained materials by flow cytometry method.
IMP/IVD/2019/000157 · from SingaporeSTROMATOLYSER WH is a reagent that lyses RBC for accurate WBC count determination WBC trimodal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compound. It i…
IMP/IVD/2019/000157 · from JapanFor in vitro diagnostic use only UF II PACK-BAC is a diluent to analyze bacteria in urine for determination of the bacterial count with the Sysmex Fully Automated Urine Particle Analyzers UF-1000i and UF-500i.
IMP/IVD/2019/000157 · from SingaporeFor in vitro diagnostic use only CELLPACK DCL is a reagent for measuring the numbers and sizes of RBC and platelets by the Hydrodynamically focussed DC detection method. With the addition of the specified lyse reagent for hemoglobin concent…
IMP/IVD/2019/000157 · from SingaporeFor in vitro diagnostic use only UX? PACK -BAC is a diluent to analyze bacteria in urine for determination of the bacterial count with the Sysmex Fully Automated Integrated Urine Analyzer UX-2000.
IMP/IVD/2019/000157 · from JapanCELLPACK is a diluent used to dilute aspirated analysis samples in order to measure an RBC count, WBC count, hemoglobin concentration and platelet count.
IMP/IVD/2019/000157 · from JapanFor in-vitro diagnostic use Measurement of platelet aggregation
IMP/IVD/2020/000838 · from FranceFor in-vitro diagnostic use Measurement of platelet aggregation
IMP/IVD/2020/000838 · from FranceFor in-vitro diagnostic use Measurement of platelet aggregation
IMP/IVD/2020/000838 · from FranceFor in-vitro diagnostic use Measurement of platelet aggregation
IMP/IVD/2020/000838 · from FranceFor in-vitro diagnostic use Measurement of platelet aggregation
IMP/IVD/2020/000838 · from FranceFor in vitro diagnostic use only, This product is used to clean the pipettes on the CN-Series fully automated blood coagulation analyzer
IMP/IVD/2019/000255 · from JapanFor in vitro diagnostic use only UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or …
IMP/IVD/2019/000157 · from SingaporeFor in vitro diagnostic use only UF-CELLPACK SF is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell SF. UF-CELLPACK SF is used to mark formed elements in urine (or …
IMP/IVD/2019/000157 · from SingaporeHypochlorite Solution is intended to clean the sample pathway by reducing possibly remaining blood and/or protein residuals from prior sample measurements in Sysmex Partec clinical flow cytometers. Hypochlorite Solution is ready to use and …
IMP/IVD/2019/000129 · from GermanyFor In Vitro Diagnostic Use. Decontamination Solution is a solution to clean sample pathways of Sysmex Partec clinical flow cytometers by reducing residual protein. It is ready to use and will be fed to the instrument via sample port manual…
IMP/IVD/2019/000129 · from GermanyFor In Vitro Diagnostic Use. Count Check Beads green is a dedicated concentrated solution of suitable beads, to be used for a quantitative quality control measurement. It is recommended for the daily quality control of Sysmex Partec clinica…
IMP/IVD/2019/000129 · from GermanyFor In Vitro Diagnostic Use. Cleaning Solution is intended to clean the sample pathway of Sysmex Partec clinical flow cytometers. Cleaning Solution is ready to use and will be fed to the instrument via sample port manually or via automated …
IMP/IVD/2019/000129 · from GermanypH=7,2 Buffer Solution for SP Automated systems is used in SP Automated Systems in combination with staining dyes for the staining according to Pappenheim and for Wright staining, both for medullary and blood smears. These stainings provid…
IMP/IVD/2025/000088 · from FranceWright Giemsa solution for SP Automated Systems is intended to be used for the fixation and differential staining of blood and bone marrow cellular structures prior to microscopic examination.
IMP/IVD/2025/000088 · from FranceSP Cleaning solution is used in SP automated systems in order to increase life of the hydraulic circuits of the SP staining machines. It is recommended to clean the equipment regularly with the SP cleaning solution.
IMP/IVD/2025/000088 · from FranceWright solution for SP Automated Systems is intended to be used for the fixation and differential staining of blood and bone marrow cellular structures, prior to microscopic examination.
IMP/IVD/2025/000088 · from FranceMay Grünwald solution for SP Automated Systems in combination with Giemsa Solution for SP Automated Systems is intended to be used for the fixation and differential staining of blood and bone marrow cellular structures prior to microscopic …
IMP/IVD/2025/000088 · from FrancepH=6.8 Buffer Solution for SP Automated systems is used in SP Automated Systems in combination with staining dyes, for the staining according to Pappenheim and for Wright staining, both for medullary and blood smears. These stainings provi…
IMP/IVD/2025/000088 · from FranceGiemsa Solution for SP Automated Systems is used in SP Automated systems for the staining according to Pappenheim for medullary and blood smears. The staining provides an aid to diagnostics in Hematology for the fixation and differential st…
IMP/IVD/2025/000088 · from FrancepH=7.0 Buffer Solution for SP Automated systems is used in SP Automated Systems in combination with staining dyes for the staining according to Pappenheim and for Wright staining, both for medullary and blood smears. These stainings provid…
IMP/IVD/2025/000088 · from FranceXN-L CHECK is intended to be used as a control for complete blood cell count (CBC), white blood cell di?erential and reticulocyte parameters on Sysmex XN-L series instruments.
IMP/IVD/2025/000085 · from JapanThe SCS-1000 is a calibrator for Sysmex haematology analysers. It is designed for the calibration and calibration verification of WBC, RBC, HGB, HCT/MCV, PLT and RET*.
IMP/IVD/2025/000085 · from United StatesXN CAL is a calibrator for Sysmex X series. It is designed for the calibration and calibration verification of WBC, RBC, HGB, HCT, PLT and RET.
IMP/IVD/2025/000085 · from United StatesWRP CHECK is used for verification of the reportable range on Sysmex XE, XT, XS, XP, KX-21N, pocH-100i and XQ-Series* hematology analyzers.
IMP/IVD/2025/000085 · from United StatesThe product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
IMP/IVD/2019/000109 · from JapanXN CAL PF is a calibrator for Sysmex X series. It is designed for the calibration and calibration verification of PLT-F.
IMP/IVD/2025/000085 · from United StatesXN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC (106/?L), HG…
IMP/IVD/2025/000085 · from United StatesXN CHECK BF is intended to be used as a control for total nuclear cell (TNC), white blood cell, red blood cell and white blood cell differential parameters on Sysmex X series instruments.
IMP/IVD/2025/000085 · from United StatesFor in vitro diagnostic use only EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H are hematology control materials primarily for intralaboratory quality control of automated, semiautomated and manual procedures that measure component…
IMP/IVD/2025/000085 · from United StatesPlatelet CHECK is a control material for quality control of PLT in the Blood Bank mode of a Sysmex automated hematology analyzer, and is used by healthcare professionals and properly trained personnel. For appropriate use of the product and…
IMP/IVD/2025/000085 · from JapanWRP CHECK EX is used for verification of the reportable range on Sysmex XR- Series*, XN series and XN-L series hematology analyzers. This product may also be used to verify reportable range for reticulocyte percent on Sysmex XT and XE serie…
IMP/IVD/2025/000085 · from JapanXN CHECK is intended to be used as a control for complete blood cell count (CBC), white blood cell differential, reticulocyte, and nucleated red blood cell (NRBC) parameters on Sysmex X series instruments.
IMP/IVD/2025/000085 · from United States-Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on Sysmex BX-Series. -Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on BioMajesty JCA-BM6010/C.
IMP/IVD/2019/000379 · from Germany-Diagnostic reagent for quantitative in vitro determination of the unsaturated iron binding capacity in serum or plasma on Sysmex BX-Series. -Diagnostic reagent for quantitative in vitro determination of the unsaturated iron binding capacit…
IMP/IVD/2019/000379 · from GermanyGlobal 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.