HORIBA India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 80 |
| Class B | Low–moderate risk | 610 |
| Class C | Moderate–high risk | 51 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
Minilysebio is a lysing solution and designed for lysing erythrocytes (RBC) and for hemoglobin determination on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Minidil LMG is a buffered isotonic solution and designed for the determination of blood cells counting, and the measurement of hematocrit on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Minidil LMG is a buffered isotonic solution and designed for the determination of blood cells counting, and the measurement of hematocrit on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Cleaner is an enzymatic solution with proteolytic action for the cleaning of HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Lysebio is a lysing solution and designed for lysing erythrocytes (RBC) and for hemoglobin determination on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Lysebio is a lysing solution and designed for lysing erythrocytes (RBC) and for hemoglobin determination on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Basolyse II is a lysing solution intended for in vitro diagnostic use and designed for lysing erythrocytes (RBC) for leucocytes (WBC) counting and differentiation on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionABX Diluent is a buffered isotonic solution and designed for sheathing and diluting leucocytes (WBC), and for the determination and differentiation of blood cells, and the measurement of hematocrit on HORIBA Medical blood cell counters.
MFG/IVD/2021/000048 · Nagpur DivisionMultical is clinical chemistry calibrator used in calibration of clinical chemistry reagents kits
MFG/IVD/2021/000048 · Nagpur DivisionA Lactate Dehydrogenase and its isoenzymes test reagent/kit is a medical device intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma.
MFG/IVD/2021/000048 · Nagpur DivisionThe N Control is to be used for monitoring the accuracy and precision of HORIBA clinical chemistry Analyzers. This control contains constituents commonly of interest in a general N control
MFG/IVD/2021/000048 · Nagpur DivisionThe Yumizen CS - Cleanser is an enzymatic solution intended for in vitro diagnostic use with proteolytic action for the cleaning.
MFG/IVD/2021/000048 · Nagpur DivisionAn amylase test reagent/kit is a medical device intended for the estimation of the enzyme amylase in serum, saliva / urine.
MFG/IVD/2021/000048 · Nagpur DivisionClinical Chemistry Control of RF/ASO/CRP as knowing concentration sample for determination of RF/ASO/CRP kits
MFG/IVD/2021/000048 · Nagpur DivisionA creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine.
MFG/IVD/2021/000048 · Nagpur DivisionA Gamma Glutamyl Transferase (GGT) and isoenzymes test reagent/kit is a medical device intended for the estimation of the enzyme Gamma Glutamyl Transferase (GGT) in serum / plasma.
MFG/IVD/2021/000048 · Nagpur DivisionThe P Control is to be used for monitoring the accuracy and precision of clinical chemistry HORIBA Analyzers. This control contains constituents commonly of interest in a general P control
MFG/IVD/2021/000048 · Nagpur DivisionA HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma.
MFG/IVD/2021/000048 · Nagpur DivisionClinical Chemistry Control of RF/ASO/CRP as knowing concentration sample for determination of RF/ASO/CRP kits
MFG/IVD/2021/000048 · Nagpur DivisionA bicarbonate/carbon dioxide test reagent/kit s a medical device for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood.
MFG/IVD/2021/000048 · Nagpur DivisionA cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma.
MFG/IVD/2021/000048 · Nagpur DivisionClinical Chemistry Reagent for detection of high-sensitivity C-Reactive Protein in human serum sample
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Apolipoprotein A-I in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandQuality control for Homocysteine assays at elevated/pathological range
MFG/IVD/2023/000078 · UttarakhandQuality control for Homocysteine assays at normal range
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of total Homocysteine in human serum or plasma
MFG/IVD/2023/000078 · UttarakhandStandard for calibration of high-sensitivity C-Reactive Protein assays
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of C-Reactive Protein in human serum sample
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Transferrin in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Apolipoprotein B in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandCalibrator for protein assays including immunoglobulins, complement factors, acute phase proteins, and iron metabolism markers
MFG/IVD/2023/000078 · UttarakhandCalibrator for Anti-Streptolysin O (ASO) assays for diagnosis of Group A Streptococcus infections
MFG/IVD/2023/000078 · Uttarakhand5-level calibration for Hemoglobin A1C assays for diabetes diagnosis and monitoring
MFG/IVD/2023/000078 · UttarakhandQuality control for Hemoglobin A1C assays at normal / non-diabetic levels
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Immunoglobulin A in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandQuality control for Hemoglobin A1C assays at elevated / diabetic levels
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Immunoglobulin G in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandQuality control for Adenosine Deaminase (ADA) assays for diagnosis of tuberculosis and assessment of liver disease.
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Immunoglobulin M in human serum and plasma sample
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Adenosine Deaminase in pleural fluid and human serum
MFG/IVD/2023/000078 · UttarakhandStandard for calibration of Adenosine Deaminase (ADA) assays for diagnosis of tuberculosis and assessment of liver disease
MFG/IVD/2023/000078 · UttarakhandQuality control for protein assays at elevated/pathological range
MFG/IVD/2023/000078 · UttarakhandStandard for calibration of Ferritin assays for assessment of iron status
MFG/IVD/2023/000078 · UttarakhandCalibration for Homocysteine assays for evaluation of cardiovascular risk, vitamin B12/folate deficiency, and diagnosis of homocystinuria
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma sample.
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Ferritin in human serum sample
MFG/IVD/2023/000078 · UttarakhandQuality control for lipid profile assays at normal physiological range
MFG/IVD/2023/000078 · UttarakhandQuality control for lipid profile assays at elevated/pathological range
MFG/IVD/2023/000078 · UttarakhandClinical Chemistry Reagent for detection of Hemoglobin A1C in human blood sample
MFG/IVD/2023/000078 · UttarakhandQuality control for lipid profile assays at elevated/pathological range
MFG/IVD/2023/000078 · UttarakhandGlobal 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.