Importer / authorised agent · Haryana · India

Sebia Diagnostics 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
435
Manufacturing
0
Import
435
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices21
Class BLow–moderate risk414
Class CModerate–high risk0
Class D (high risk)Highest-risk devices0

CDSCO device licences

ANTI-TRANSFERRIN(E) - PER · Class BIMPORT · 2026-03-17

To be used together with HYDRAGEL 6 ß2 TRANSFERRIN(E) (SM)

IMP/IVD/2020/000718 · from France
HYDRAGEL 6 ß2 TRANSFERRIN(E) · Class BIMPORT · 2026-03-17

The 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 France
CAPILLARYS 3 OCTA · Class AIMPORT · 2026-03-09

This 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 France
HYDRASYS 2 SCAN FOCUSING · Class AIMPORT · 2026-03-09

These 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 France
ASSIST · Class AIMPORT · 2026-03-09

This 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 France
TUBE LOADER CAPILLARYS 3 · Class AIMPORT · 2026-03-09

The 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 France
MINICAP FLEX-PIERCING · Class AIMPORT · 2026-03-09

This 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 France
CAPILLARYS 3 TERA · Class AIMPORT · 2026-03-09

This 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 France
RACK CONVEYOR CAPILLARYS 3 · Class AIMPORT · 2026-03-09

The 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 France
CAPILLARYS 3 DBS · Class AIMPORT · 2026-03-09

CAPILLARYS 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 France
CAPILLARYS / MINICAP URINE · Class BIMPORT · 2026-02-12

The 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 France
CAPI 3 NEONAT Hemolysing Solution · Class BIMPORT · 2026-02-12

To Dilute and hemolyze the total blood samples dried on the Guthrie Filter paper and the Control blood.

IMP/IVD/2020/000718 · from France
CAPI 3 NEONAT Hb · Class BIMPORT · 2026-02-12

The 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 France
CAPI 3 NEONAT Hb AF CONTROL · Class BIMPORT · 2026-02-12

The 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 France
HYDRAGEL 30 LIPOPROTEIN(E) · Class BIMPORT · 2026-01-27

The 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 France
HYDRAGEL 15 LIPOPROTEIN(E) · Class BIMPORT · 2026-01-27

The 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 France
HYDRAGEL 15 ISO-CK · Class BIMPORT · 2026-01-27

The 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 France
HYDRAGEL 30 ISO-CK · Class BIMPORT · 2026-01-27

The 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 France
HYDRAGEL 7 ISO-CK · Class BIMPORT · 2026-01-27

The 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 France
A1C/CE - CAPILLARY BLOOD SAMPLE KIT (A) · Class BIMPORT · 2026-01-14

The "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 France
5 von WILLEBRAND MULTIMERS VISUALIZATION KIT · Class BIMPORT · 2026-01-14

This 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 France
HYDRAGEL 15 ACID(E) HEMOGLOBIN(E) · Class BIMPORT · 2026-01-14

These 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 France
CAPICLEAN · Class BIMPORT · 2026-01-14

CAPICLEAN 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 France
CAPI 3 URINE · Class BIMPORT · 2026-01-14

This device is designed for the preparation of human urine samples for analysis with the CAPI 3 URINE procedure.

IMP/IVD/2020/000718 · from France
Hb A1c CAPILLARY CALIBRATORS (2) · Class BIMPORT · 2026-01-14

This 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 France
CAPILLARYS 3 CAPICLEAN · Class BIMPORT · 2026-01-14

For 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 France
CAPILLARYS 3 WASH SOLUTION (1) · Class BIMPORT · 2026-01-14

Used for the cleaning of the staining compartment.

IMP/IVD/2020/000718 · from France
CAPILLARYS Hb A1c · Class BIMPORT · 2026-01-14

The 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 France
CAPILLARYS HEMOGLOBIN(E) BUFFER · Class BIMPORT · 2026-01-14

Alkaline 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 France
CAPILLARYS HEMOGLOBIN(E) · Class BIMPORT · 2026-01-14

The 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 France
CAPI 3 PROTEIN(E) 6 · Class BIMPORT · 2026-01-14

he 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 France
HYDRAGEL 11 von WILLEBRAND MULTIMERS · Class BIMPORT · 2026-01-14

The 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 France
HYDRAGEL 15 ISO-LDH · Class BIMPORT · 2026-01-14

These 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 France
CAPI 3 IMMUNOTYPING · Class BIMPORT · 2026-01-14

The 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 France
DTT DILUENT (IF / IT) · Class BIMPORT · 2026-01-14

The 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 France
CAPI 3 HEMOGLOBIN(E) · Class BIMPORT · 2026-01-14

The 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 France
CAPI 3 Hb A1c · Class BIMPORT · 2026-01-14

This 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 France
CLEAN PROTECT · Class BIMPORT · 2026-01-14

CLEAN PROTECT concentrated solution contains a preservative

IMP/IVD/2020/000718 · from France
CDT SAMPLES TREATMENT SOLUTION · Class BIMPORT · 2026-01-14

This reagent is designed for treatment of interfering samples in the capillary electrophoresis system.

IMP/IVD/2020/000718 · from France
CAPI 3 CDT · Class BIMPORT · 2026-01-14

This 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 France
CSF CONTROL · Class BIMPORT · 2026-01-14

The 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 France
DESTAINING SOLUTION (10) · Class BIMPORT · 2026-01-14

Used for destaining, that is removal of excess and background stain from the gels

IMP/IVD/2020/000718 · from France
Hb AFSC CONTROL · Class BIMPORT · 2026-01-14

The 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 France
ENZYCONTROL · Class BIMPORT · 2026-01-14

This 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 France
FLUIDIL · Class BIMPORT · 2026-01-14

Used to dilute samples with hindered diffusion through the sample applicator teeth.

IMP/IVD/2020/000718 · from France
(GAM. K. L) ANTISERA AND FIXATIVE SOLUTION BOX (SM) · Class BIMPORT · 2026-01-14

These 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 France
CDT MINICAP CALIBRATORS (2 levels) · Class BIMPORT · 2026-01-14

The 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 France
Hb A1c CAPILLARY CALIBRATORS (5x2) · Class BIMPORT · 2026-01-14

This 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 France
Hb AF CONTROL · Class BIMPORT · 2026-01-14

he 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 France
CAPILLARYS PROTEIN(E) 6 · Class BIMPORT · 2026-01-14

The 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 France

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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