M/s. Agappe Diagnostics Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 85 |
| Class B | Low–moderate risk | 774 |
| Class C | Moderate–high risk | 52 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
Probe cleaner for Hematology Analyzer is used for periodic cleaning of sample probe and daily maintenance of the circuit system.It is used for Mispa HX series and other compatible Hematology analyzer.
MFG/IVD/2020/000005 · KeralaRenin Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of Renin on the MISPA-i60, MISPA-i121 and other compactible types of CLIA analyzers.
MFG/IVD/2020/000005 · KeralaDiluent for Hematology Analyzer is intended to be used for diluting the sample to prepare cell suspension before hemocyte analysis. It is used in Mispa HX series and other compatible hematology analyzers.
MFG/IVD/2020/000005 · KeralaThis device is intended to be used for destroy red blood cells to release haemoglobin before blood cell analysis, so as to carry out haemoglobin quantitative determination. It is used in Mispa HX series and other compatible Hematology analy…
MFG/IVD/2020/000005 · KeralaLyse -1 for Hematology analyzer is intended to be used for destroy red blood cells to release haemoglobin before blood cell analysis, so as to carry out haemoglobin quantitative determination. It is used in Mispa HX series and other compati…
MFG/IVD/2020/000005 · KeralaMulti-Drug Rapid Test Panel (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test panels are provided with and withou…
IMP/IVD/2023/000022 · from ChinaMulti-Drug Rapid Test Cup (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test cups are provided with and without Ad…
IMP/IVD/2023/000022 · from ChinaMulti-Line Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test cassettes are provided with and …
IMP/IVD/2023/000022 · from ChinaMulti-Drug Rapid Test Cup (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test cups are provided with and without Ad…
IMP/IVD/2023/000022 · from ChinaMulti-Line Rapid Test Cup (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test cups are provided with and without Ad…
IMP/IVD/2023/000022 · from ChinaMulti-Line Rapid Test Cassette (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in Oral Fluid at the certain cut-off concentrations. The DOA test cassettes are provided…
IMP/IVD/2023/000022 · from ChinaMulti-Drug Rapid Test Dipcard (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test dipcards are provided with and wi…
IMP/IVD/2023/000022 · from ChinaMulti-Drug Rapid Test Cup with Indicator (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in Oral Fluid at the certain cut-off concentrations. The DOA test cups are pro…
IMP/IVD/2023/000022 · from ChinaMulti-Drug Rapid Test Cup (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the certain cut-off concentrations. The DOA test cups are provided with and without Ad…
IMP/IVD/2023/000022 · from ChinaSeronorm® Cardiac Acute Lyo L-3 is intended for use as an assayed quality control material to monitor the precision and trueness of laboratory measurement procedures.
IMP/IVD/2024/000051 · from NorwaySeronorm® Cardiac Acute Lyo L-1B is intended for use as an assayed quality control material to monitor the precision and trueness of laboratory measurement procedures.
IMP/IVD/2024/000051 · from NorwaySeronorm® Cardiac Acute Lyo L-1A is intended for use as an assayed quality control material to monitor the precision and trueness of laboratory measurement procedures.
IMP/IVD/2024/000051 · from NorwaySeronorm® Cardiac Acute Lyo L-2 is intended for use as an assayed quality control material to monitor the precision and trueness of laboratory measurement procedures.
IMP/IVD/2024/000051 · from NorwayAnti-Thyroglobulin Antibody (TgAb) CLIA Cartridge Reagent Set is intended for quantitative measurement of anti-thyroglobulin antibodies in serum or plasma. The TgAb CLIA Cartridge Reagent kit is a cartridge-based immunoassay, applicable to …
MFG/IVD/2020/000005 · KeralaAnti-thyroid peroxidase antibody (TPOAb) CLIA Cartridge Reagent is for in vitro diagnostic use with the MISPA-i60/MISPA-i121 System for the quantitative measurement of anti-thyroid peroxidase antibodies in serum or plasma. The product is fo…
MFG/IVD/2020/000005 · KeralaIt is used for quantitative in vitro detection of the content of pH value, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), potassium ion, sodium ion, chloride ion, calcium ion, glucose, lactate and hematocrit in hum…
IMP/IVD/2026/000017 · from ChinaRenin CLIA Calibrator use in the calibration of the automated MISPA-i60/MISPA-i121 System for quantitative measurement of active renin in human serum and plasma. This product is for professional use only. The Renin CLIA Calibrator kit is a …
MFG/IVD/2020/000005 · KeralaAldosterone CLIA Cartridge Reagent is intended for the quantitative measurement of aldosterone in human serum, plasma or urine. The Aldosterone CLIA reagent kit is a cartridge-based immunoassay, applicable to MISPA-i60, MISPA-i121 and other…
MFG/IVD/2020/000005 · KeralaRenin CLIA Cartridge Reagent is intended for quantitative measurement of active renin in human serum and plasma. The Renin CLIA Cartridge Reagent kit is a cartridge-based immunoassay, applicable to MISPA-i60, MISPA-i121 and other similar ty…
MFG/IVD/2020/000005 · KeralaFor in vitro diagnostic use in the calibration of the automated MISPA-i60/MISPA-i121 System for the quantitative determination of aldosterone in human serum, plasma or urine. This product is for professional use only. The Aldosterone CLIA C…
MFG/IVD/2020/000005 · KeralaUsed for calibration of clinical chemistry test using enzymatic bilirubin reagents .
MFG/IVD/2020/000005 · Keralato be used for blood cell counting sizing and WBC differentiation hemoglobin determination on mispa count plus hematology Analyzer.
IMP/IVD/2019/000427 · from FranceThe Installation Kit for MISPA-i121 (CLIA) is intended for one-time use exclusively during the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases of equipment commissioning. This is ap…
MFG/IVD/2020/000005 · KeralaEnzymatic Bilirubin Direct Reagent is intended for the quantification of direct Bilirubin in serum and plasma
MFG/IVD/2020/000005 · KeralaGlial Fibrillary Acidic Protein (GFAP) CLIA Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of GFAP on the MISPA-i60, MISPA-i121 and other similar type of …
MFG/IVD/2020/000005 · KeralaGlial Fibrillary Acidic Protein (GFAP) CLIA Cartridge is intended for the quantitative measurement of GFAP (Glial Fibrillary Acidic Protein) in human plasma or serum. GFAP CLIA Cartridge Reagent kit is a cartridge-based immunoassay, applica…
MFG/IVD/2020/000005 · KeralaThe Installation Kit for MISPA-i60 (CLIA) is intended for one-time use exclusively during the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases of equipment commissioning. This is app…
MFG/IVD/2020/000005 · KeralaEnzymatic Bilirubin Total Reagent is intended for the quantification of Total Bilirubin in serum and plasma
MFG/IVD/2020/000005 · KeralaGlial Fibrillary Acidic Protein (GFAP) CLIA Calibrator is intended for use in the calibration of the MISPA-i60/MISP-i121 system for the quantitative measurement of GFAP (Glial Fibrillary Acidic Protein) in human serum or plasma. The GFAP CL…
MFG/IVD/2020/000005 · KeralaThis product is used clinically to conduct qualitative or quantitative analysis of the clinical chemistry and electrolyte parameters in serum, plasma and urine samples from human bodies, including measurement of the electrolyte content in b…
IMP/IVD/2023/000093 · from JapanHaemoglobin Control is intended for monitoring the accuracy and precision in Mispa HbX hemoglobin analyzer and other similar analyzers.
MFG/IVD/2020/000005 · KeralaHematology Cartridge Kit (Veterinary) is designed for performing complete blood counts (CBC) with differential, RBC, WBC, PLT, Hemoglobin measurement, and cell morphology analysis in veterinary whole blood samples. It is intended for use wi…
MFG/IVD/2020/000005 · KeralaPhosphorylated Tau at threonine-217 (pTau 217) CLIA Control (Plasma) is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of pTau 217 plasma on the MISPA-i60, MISPA-i12…
MFG/IVD/2020/000005 · KeralaBeta-Amyloid 1-42 CLIA Control (Plasma) is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of Beta-Amyloid 1-42 Plasma immunoassay on the MISPA-i60, MISPA-i121 and ot…
MFG/IVD/2020/000005 · KeralaVitamin D control is used as an assayed quality control to monitor the precision of laboratory testing procedures for Vitamin D analysis in both semi and fully auto analyzers.
MFG/IVD/2020/000005 · KeralaPATHFAST is a clinical laboratory instrument to measure various clinical parameters quickly and accurately using whole blood, plasma, serum or other body fluid as samples.
IMP/IVD/2025/000091 · from JapanPATHFAST Myo is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of Myoglobin (Myo) in human anticoagulated whole blood and plasma. PATHFAST Myo is a devic…
IMP/IVD/2025/000091 · from JapanPATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in human anticoagulated whol…
IMP/IVD/2025/000091 · from JapanPATHFAST hs-cTnI is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of cardiac Troponin I (cTnI) in human anticoagulated whole blood and plasma. PATHFAST …
IMP/IVD/2025/000091 · from JapanPATHFAST hsCRP is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of C-reactive protein (CRP) in human serum, anticoagulated whole blood and plasma. PATHF…
IMP/IVD/2025/000091 · from JapanPATHFAST B.R.A.H.M.S PCT Control is used for quality control of PATHFAST B.R.A.H.M.S PCT chemiluminescent immunoassay on PATHFAST automated analyzer. PATHFAST B.R.A.H.M.S PCT Control is a device for near patient testing (NPT).
IMP/IVD/2025/000091 · from JapanPATHFAST D-Dimer is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of D-dimer in whole blood or plasma. PATHFAST D-Dimer is a device for near patient tes…
IMP/IVD/2025/000091 · from JapanPATHFAST Presepsin is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of presepsin in human anticoagulated whole blood and plasma. PATHFAST Presepsin is a…
IMP/IVD/2025/000091 · from JapanPATHFAST Presepsin Control is used for quality control of PATHFAST Presepsin chemiluminescent immunoassay on PATHFAST automated analyzer. PATHFAST Presepsin Control is a device for near patient testing (NPT).
IMP/IVD/2025/000091 · from JapanPATHFAST BRAHMS PCT is a product for in-vitro diagnostic use with the in vitro diagnostic (IVD) automated analyser PATHFAST for the quantitative measurement of Procalcitonin (PCT) in human serum, anticoagulated whole blood and plasma. PATHF…
IMP/IVD/2025/000091 · from JapanGlobal 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.