Sebia Diagnostics India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 21 |
| Class B | Low–moderate risk | 414 |
| Class C | Moderate–high risk | 0 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
To be used together with HYDRAGEL 6 ß2 TRANSFERRIN(E) (SM)
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 6 ß2 TRANSFERRIN(E) kit is designed for the qualitative detection of ß2 transferrin fraction in human biological fluids. The aim of this procedure is to characterize the desialilated fraction of the transferrin by immunofixatio…
IMP/IVD/2020/000718 · from FranceThis device is multitask automated electrophoresis capillary instrument. It performs automatically all the sequences of the electrophoresis directly from primary tubes to electrophoretic profile: sample identification, sample dilution, capi…
IMP/IVD/2020/000718 · from FranceThese devices are multiparameter semi-automated instruments which perform, read and memorize any agarose gel electrophoresis. The automated electrophoresis steps are performed in sequence: sample application, migration, incubation, staining…
IMP/IVD/2020/000718 · from FranceThis device is designed for sample preparation and dilution. It is designed to deliver precise volumes of sample directly from primary tubes to HYDRASYS disposable sample applicators. It allows pre-dilutions for various immunofixation techn…
IMP/IVD/2020/000718 · from FranceThe loading capacity of the CAPILLARYS 3 TERA instrument may be increased by the addition of a tube loader (PN 1249) and a rack conveyor (PN 1250), these devices allow to connect up to 3 CAPILLARYS 3 TERA instruments due to the addition of …
IMP/IVD/2020/000718 · from FranceThis device is multitask automated electrophoresis capillary instrument. It performs automatically all the sequences of the electrophoresis directly from primary tubes to electrophoretic profile: sample identification, sample dilution, capi…
IMP/IVD/2020/000718 · from FranceThis device is multitask automated electrophoresis capillary instrument. It performs automatically all the sequences of the electrophoresis directly from primary tubes to electrophoretic profile: sample identification, sample dilution, capi…
IMP/IVD/2020/000718 · from FranceThe loading capacity of the CAPILLARYS 3 TERA instrument may be increased by the addition of a tube loader (PN 1249) and a rack conveyor (PN 1250), these devices allow to connect up to 3 CAPILLARYS 3 TERA instruments due to the addition of …
IMP/IVD/2020/000718 · from FranceCAPILLARYS 3 DBS is a capillary electrophoresis automated instrument intended for the analysis of human blood samples collected on filter paper for SEBIA In Vitro Diagnostic capillary electrophoresis procedures. This device is intended for …
IMP/IVD/2020/000718 · from FranceThe CAPILLARYS / MINICAP URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS and MINICAP instruments.
IMP/IVD/2020/000718 · from FranceTo Dilute and hemolyze the total blood samples dried on the Guthrie Filter paper and the Control blood.
IMP/IVD/2020/000718 · from FranceThe CAPI 3 NEONAT Hb kit is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart?s) in blood from human new-born collected on filter paper. This qualitative analysis is performed by capill…
IMP/IVD/2020/000718 · from FranceThe CAPI 3 NEONAT Hb AF CONTROL is intended for the migration control and the quality control of SEBIA capillary electrophoresis procedures. It must be used with the CAPI 3 NEONAT Hb kit. This device is intended for professional use only. F…
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 7, 15 and 30 LIPOPROTEIN(E) kits are designed for determination of lipoprotein profiles in human serum. Each agarose gel is intended to run: ? 7 samples with the HYDRAGEL 7 LIPOPROTEIN(E) kit, ? 15 samples with the HYDRAGEL 15 …
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 7, 15 and 30 LIPOPROTEIN(E) kits are designed for determination of lipoprotein profiles in human serum. Each agarose gel is intended to run: ? 7 samples with the HYDRAGEL 7 LIPOPROTEIN(E) kit, ? 15 samples with the HYDRAGEL 15 …
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 7, 15 and 30 ISO-CK kits are designed for the identification and quantification of the three creatine kinase (CK) isoenzymes in human serum by electrophoresis on alkaline buffered (pH 8.4) agarose gels. The kits are used in con…
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 7, 15 and 30 ISO-CK kits are designed for the identification and quantification of the three creatine kinase (CK) isoenzymes in human serum by electrophoresis on alkaline buffered (pH 8.4) agarose gels. The kits are used in con…
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 7, 15 and 30 ISO-CK kits are designed for the identification and quantification of the three creatine kinase (CK) isoenzymes in human serum by electrophoresis on alkaline buffered (pH 8.4) agarose gels. The kits are used in con…
IMP/IVD/2020/000718 · from FranceThe "A1c/CE ? Capillary blood sample kit (A)" device is designed for collection, hemolysis and transportation of blood samples for their analysis with the SEBIA capillary electrophoresis procedures.
IMP/IVD/2020/000718 · from FranceThis device is designed for the detection and the analysis of the distribution of von Willebrand factor multimers in human plasma by agarose gel electrophoresis and immunofixation, with the semi automated HYDRASYS 2 instrument.
IMP/IVD/2020/000718 · from FranceThese devices are designed for separation of the normal hemoglobin A, abnormal hemoglobins S and C and fetal hemoglobin F, by electrophoresis on acidic agarose gels.
IMP/IVD/2020/000718 · from FranceCAPICLEAN solution is used for cleaning of the sample probe in automated systems CAPILLARYS and MINICAP, SEBIA, for capillary electrophoresis, during the CAPICLEAN cleaning sequence. NOTE : A CAPICLEAN cleaning sequence includes the sample …
IMP/IVD/2020/000718 · from FranceThis device is designed for the preparation of human urine samples for analysis with the CAPI 3 URINE procedure.
IMP/IVD/2020/000718 · from FranceThis device is designed for the calibration of capillary electrophoretic quantification of human glycated hemoglobin A1c according to the IFCC and NGSP requirements
IMP/IVD/2020/000718 · from FranceFor the sample probe cleaning in automated instrument for capillary electrophoresis CAPILLARYS 3, SEBIA, during the CAPICLEAN cleaning sequence. For In Vitro diagnostic use.
IMP/IVD/2020/000718 · from FranceUsed for the cleaning of the staining compartment.
IMP/IVD/2020/000718 · from FranceThe CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. Th…
IMP/IVD/2020/000718 · from FranceAlkaline buffer for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D) by capillary electrophoresis with the CAPILLARYS automatic system.
IMP/IVD/2020/000718 · from FranceThe CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with th…
IMP/IVD/2020/000718 · from Francehe CAPI 3 PROTEIN(E) 6 kit is designed for the separation of human serum proteins by capillary electrophoresis in alkaline buffer (pH 9.9) with the CAPILLARYS 3 instrument. Normal serum proteins separate into six major fractions. The CAPILL…
IMP/IVD/2020/000718 · from FranceThe HYDRAGEL 5 von WILLEBRAND MULTIMERS and HYDRAGEL 11 von WILLEBRAND MULTIMERS kits are designed for the detection and the analysis of the distribution of von Willebrand factor multimers in human plasma by agarose gel electrophoresis and …
IMP/IVD/2020/000718 · from FranceThese devices are designed for the identification and quantification of the five lactate dehydrogenase (LD) isoenzymes in human serum by electrophoresis on alkaline buffered (pH 8.4) agarose gels.
IMP/IVD/2020/000718 · from FranceThe CAPI 3 IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS 3 instrument, SEBIA, for capillary electrophoresis. It is used in conjunct…
IMP/IVD/2020/000718 · from FranceThe DTT Diluent (IF / IT) is intended for the reconstitution of a Dithiothreitol (DTT) vial for the preparation of a DTT 0.5 M reducing solution that is used to depolymerize monoclonal proteins, for the analysis
IMP/IVD/2020/000718 · from FranceThe CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buf…
IMP/IVD/2020/000718 · from FranceThis device is designed for separation and quantification of the HbA1c, glycosylated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 system.
IMP/IVD/2020/000718 · from FranceCLEAN PROTECT concentrated solution contains a preservative
IMP/IVD/2020/000718 · from FranceThis reagent is designed for treatment of interfering samples in the capillary electrophoresis system.
IMP/IVD/2020/000718 · from FranceThis device is designed for the separation of the transferrin isoforms in human serum and the quantification of the CDT (carbohydrate deficient transferrin) by capillary electrophoresis in alkaline buffer (pH 8.8) with the CAPILLARYS 3 inst…
IMP/IVD/2020/000718 · from FranceThe CSF Control is designed for the quality control of the detection of immunoglobulins G contained in human serum and cerebrospinal fluid by immunofixation with HYDRAGEL CSF* and HYDRAGEL CSF ISOFOCUSING* procedures. The CSF Control should…
IMP/IVD/2020/000718 · from FranceUsed for destaining, that is removal of excess and background stain from the gels
IMP/IVD/2020/000718 · from FranceThe Hb AFSC Control is designed for the quality control of electrophoretic separations of human hemoglobins with HYDRAGEL HEMOGLOBIN(E)*, HYDRAGEL ACID(E) HEMOGLOBIN(E)*, CAPILLARYS / CAPI 3 / MINICAP HEMOGLOBIN(E)*, CAPILLARYS NEONAT Hb* a…
IMP/IVD/2020/000718 · from FranceThis device is designed for the quality control of electrophoretic quantification of human serum lactate dehydrogenase (LD) isoenzymes and creatine kinase (CK) isoenzymes on agarose gel.
IMP/IVD/2020/000718 · from FranceUsed to dilute samples with hindered diffusion through the sample applicator teeth.
IMP/IVD/2020/000718 · from FranceThese devices contain specific antisera with or without fixative solution for agarose gel immunofixation techniques. They are specific for the immunofixation procedure with the standard mask in conjunction with the semi-automated HYDRASYS e…
IMP/IVD/2020/000718 · from FranceThe CDT MINICAP CALIBRATORS (2 levels) are designed for the calibration of the quantification method of the CDT-IFCC fraction (calibrated disialotransferrin) with the SEBIA MINICAP CDT-IFCC capillary electrophoresis procedure performed with…
IMP/IVD/2020/000718 · from FranceThis device is designed for the calibration of capillary electrophoretic quantification of human glycated hemoglobin A1c according to the IFCC and NGSP requirements
IMP/IVD/2020/000718 · from Francehe Hb AF Control is designed for the migration control before starting a new analysis sequence and for the qualitative quality control for human hemoglobins A and F, with the SEBIA electrophoresis procedures : - CAPILLARYS NEONAT Hb used wi…
IMP/IVD/2020/000718 · from FranceThe CAPILLARYS PROTEIN(E) 6 kit is designed for the separation of human serum and urine proteins in alkaline buffer (pH 9.9) by capillary electrophoresis with the CAPILLARYS System. Normal serum proteins separate into six major fractions. U…
IMP/IVD/2020/000718 · from FranceGlobal 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.