Domestic manufacturer · Uttarakhand · India

HORIBA India Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
741
Manufacturing
384
Import
357
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices80
Class BLow–moderate risk610
Class CModerate–high risk51
Class D (high risk)Highest-risk devices0

CDSCO device licences

Minilysebio 0.4L · Class BMFG · 2026-04-22

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 Division
ABX Minidil LMG 10L · Class BMFG · 2026-04-22

ABX 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 Division
ABX Minidil LMG 20L · Class BMFG · 2026-04-22

ABX 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 Division
ABX Cleaner 1L · Class BMFG · 2026-04-22

ABX Cleaner is an enzymatic solution with proteolytic action for the cleaning of HORIBA Medical blood cell counters.

MFG/IVD/2021/000048 · Nagpur Division
ABX Lysebio 0.4L · Class BMFG · 2026-04-22

ABX 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 Division
ABX Lysebio 1L · Class BMFG · 2026-04-22

ABX 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 Division
ABX Basolyse II 1L · Class BMFG · 2026-04-22

ABX 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 Division
ABX Diluent 20L · Class BMFG · 2026-04-22

ABX 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 Division
Calibrator for Clinical Chemistry · Class BMFG · 2026-04-21

Multical is clinical chemistry calibrator used in calibration of clinical chemistry reagents kits

MFG/IVD/2021/000048 · Nagpur Division
Lactate Dehydrogenase and its isoenzymes test reagents/kits · Class BMFG · 2026-04-21

A 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 Division
N - Control for Clinical Chemistry · Class BMFG · 2026-04-21

The 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 Division
Cleaner Reagents · Class BMFG · 2026-04-21

The Yumizen CS - Cleanser is an enzymatic solution intended for in vitro diagnostic use with proteolytic action for the cleaning.

MFG/IVD/2021/000048 · Nagpur Division
Amylase test reagents/kits · Class BMFG · 2026-04-21

An 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 Division
Level 1 - Control for Clinical Chemistry RF/ASO/CRP · Class BMFG · 2026-04-21

Clinical Chemistry Control of RF/ASO/CRP as knowing concentration sample for determination of RF/ASO/CRP kits

MFG/IVD/2021/000048 · Nagpur Division
Creatinine test reagents/kits · Class BMFG · 2026-04-21

A creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine.

MFG/IVD/2021/000048 · Nagpur Division
Gamma Glutamyl Transferase (GGT) and isoenzymes test reagents/kits · Class BMFG · 2026-04-21

A 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 Division
P - Control for Clinical Chemistry · Class BMFG · 2026-04-21

The 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 Division
HDL cholesterol test reagents/kits · Class BMFG · 2026-04-21

A HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma.

MFG/IVD/2021/000048 · Nagpur Division
Level 2 - Control for Clinical Chemistry RF/ASO/CRP · Class BMFG · 2026-04-21

Clinical Chemistry Control of RF/ASO/CRP as knowing concentration sample for determination of RF/ASO/CRP kits

MFG/IVD/2021/000048 · Nagpur Division
Bicarbonate / Carbon dioxide test reagents/kits · Class BMFG · 2026-04-21

A 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 Division
Cholesterol (total) test reagents/kits · Class BMFG · 2026-04-21

A cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma.

MFG/IVD/2021/000048 · Nagpur Division
Yumizen CS C-Reactive Protein-hs (CRP-hs) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of high-sensitivity C-Reactive Protein in human serum sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Apolipoprotein A-I (APO A-I) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Apolipoprotein A-I in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Homocysteine Control LEVEL II 1 X 1 mL · Class BMFG · 2026-04-08

Quality control for Homocysteine assays at elevated/pathological range

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Homocysteine Control LEVEL I 1 X 1 mL · Class BMFG · 2026-04-08

Quality control for Homocysteine assays at normal range

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Homocysteine 25.4 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of total Homocysteine in human serum or plasma

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS CRP-hs Standard 1 X 5 mL · Class BMFG · 2026-04-08

Standard for calibration of high-sensitivity C-Reactive Protein assays

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS C-Reactive Protein (CRP) 104 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of C-Reactive Protein in human serum sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Transferrin (TRF) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Transferrin in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Apolipoprotein B (APO B) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Apolipoprotein B in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Protein Calibrators 5 X 1 mL · Class BMFG · 2026-04-08

Calibrator for protein assays including immunoglobulins, complement factors, acute phase proteins, and iron metabolism markers

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS ASO Calibrator 1 X 1 mL · Class BMFG · 2026-04-08

Calibrator for Anti-Streptolysin O (ASO) assays for diagnosis of Group A Streptococcus infections

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS HbA1c CAL 5 X 1 mL · Class BMFG · 2026-04-08

5-level calibration for Hemoglobin A1C assays for diabetes diagnosis and monitoring

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Hemoglobin A1C Control NORMAL 1 X 0.5 mL · Class BMFG · 2026-04-08

Quality control for Hemoglobin A1C assays at normal / non-diabetic levels

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Immunoglobulin A (Ig A) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Immunoglobulin A in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Hemoglobin A1C Control ELEVATED 1 X 0.5 mL · Class BMFG · 2026-04-08

Quality control for Hemoglobin A1C assays at elevated / diabetic levels

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Immunoglobulin G (Ig G) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Immunoglobulin G in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS ADA Controls Level I & II 2 X 1 mL · Class BMFG · 2026-04-08

Quality control for Adenosine Deaminase (ADA) assays for diagnosis of tuberculosis and assessment of liver disease.

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Immunoglobulin M (Ig M) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Immunoglobulin M in human serum and plasma sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Adenosine Deaminase (ADA) 42 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Adenosine Deaminase in pleural fluid and human serum

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS ADA Standard 1 X 1 mL · Class BMFG · 2026-04-08

Standard for calibration of Adenosine Deaminase (ADA) assays for diagnosis of tuberculosis and assessment of liver disease

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Protein Control Serum LEVEL II 3 X 1 mL · Class BMFG · 2026-04-08

Quality control for protein assays at elevated/pathological range

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Ferritin Standard 1 X 3 mL · Class BMFG · 2026-04-08

Standard for calibration of Ferritin assays for assessment of iron status

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Homocysteine Standards 5 X 1 mL · Class BMFG · 2026-04-08

Calibration for Homocysteine assays for evaluation of cardiovascular risk, vitamin B12/folate deficiency, and diagnosis of homocystinuria

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS UIBC 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma sample.

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Ferritin 60 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Ferritin in human serum sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Lipid Control Serum LEVEL I 3 X 1 mL · Class BMFG · 2026-04-08

Quality control for lipid profile assays at normal physiological range

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Lipid Control Serum LEVEL II 3 X 1 mL · Class BMFG · 2026-04-08

Quality control for lipid profile assays at elevated/pathological range

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Hemoglobin A1C-DIRECT (HbA1C-DIR) 75 mL · Class BMFG · 2026-04-08

Clinical Chemistry Reagent for detection of Hemoglobin A1C in human blood sample

MFG/IVD/2023/000078 · Uttarakhand
Yumizen CS Protein Control Serum LEVEL I 3 X 1 mL · Class BMFG · 2026-04-08

Quality control for lipid profile assays at elevated/pathological range

MFG/IVD/2023/000078 · Uttarakhand

Global footprint

Cross-rail

The 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.

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