OUSHVAA™
Importer / authorised agent · Haryana · India

SNIBE DIAGNOSTIC (India) Private Limited.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
591
Manufacturing
0
Import
591
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices29
Class BLow–moderate risk385
Class CModerate–high risk169
Class D (high risk)Highest-risk devices8

CDSCO device licences

Total T4 (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total thyroxine (Total T4) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Total T3 (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total triiodothyronine (Total T3) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Complement C4 Calibrators · Class BIMPORT · 2026-05-04

The Complement C4 Calibrators are intended for performing the calibration procedures with Biossays Complement C4 (Immunoturbidimetric) assay when used for the quantitative determination of Complement C4 (C4).

IMP/IVD/2023/000036 · from China
Anti-HAV (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the qualitative determination of Anti-HAV in human serum and plasma.

IMP/IVD/2023/000036 · from China
Anti-Cardiolipin IgA (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of anti-Cardiolipin IgA (aCL IgA) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Anti-PR3 IgG (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-PR3 IgG (PR3 IgG) in human serum and Plasma.

IMP/IVD/2023/000036 · from China
Adenosine Deaminase Controls · Class BIMPORT · 2026-05-04

The Adenosine Deaminase Controls are intended for performing quality control procedures with Biossays Adenosine Deaminase (Peroxidase) assay when used for the quantitative determination of Adenosine Deaminase (ADA).

IMP/IVD/2023/000036 · from China
Adenovirus IgM (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the qualitative determination of Adenovirus (ADV) IgM in human serum and plasma.

IMP/IVD/2023/000036 · from China
Complement C3 Controls · Class BIMPORT · 2026-05-04

The Complement C3 Controls are intended for performing quality control procedures with Biossays Complement C3 (Immunoturbidimetric) assay when used for the quantitative determination of Complement C3 (C3).

IMP/IVD/2023/000036 · from China
Complement C4 Controls · Class BIMPORT · 2026-05-04

The Complement C4 Controls are intended for performing quality control procedures with Biossays Complement C4 (Immunoturbidimetric) assay when used for the quantitative determination of Complement C4 (C4).

IMP/IVD/2023/000036 · from China
Progesterone (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Progesterone (PROG) in human serum and plasma.

IMP/IVD/2023/000036 · from China
HAV IgM (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the qualitative determination of HAV IgM in human serum and plasma.

IMP/IVD/2023/000036 · from China
Testosterone (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Testosterone (TEST) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Bicarbonate Calibrator · Class BIMPORT · 2026-05-04

The Bicarbonate Calibrator is intended for performing the calibration procedures with Biossays Bicarbonate (PEPC Enzymatic) assay when used for the quantitative determination of carbon dioxide (CO2 ).

IMP/IVD/2023/000036 · from China
Adenosine Deaminase (Peroxidase) · Class BIMPORT · 2026-05-04

The kit is an in vitro diagnostic reagent for the quantitative determination of adenosine deaminase (ADA) activity in human serum, plasma, hydrothorax, ascites, and cerebrospinal fluid.

IMP/IVD/2023/000036 · from China
Anti-Cardiolipin (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of anti-Cardiolipin (aCL) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Androstenedione (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Androstenedione in human serum and plasma.

IMP/IVD/2023/000036 · from China
Adenosine Deaminase Calibrator · Class BIMPORT · 2026-05-04

The Adenosine Deaminase Calibrator is intended for performing the calibration procedures with Biossays Adenosine Deaminase (Peroxidase) assay when used for the quantitative determination of Adenosine Deaminase (ADA).

IMP/IVD/2023/000036 · from China
Complement C3 (Immunoturbidimetric) · Class BIMPORT · 2026-05-04

The kit is an in vitro diagnostic reagent for the quantitative determination of Complement C3 (C3) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Complement C3 Calibrators · Class BIMPORT · 2026-05-04

The Complement C3 Calibrators are intended for performing the calibration procedures with Biossays Complement C3 (Immunoturbidimetric) assay when used for the quantitative determination of Complement C3 (C3).

IMP/IVD/2023/000036 · from China
Bicarbonate(PEPC Enzymatic) · Class BIMPORT · 2026-05-04

The kit is an in vitro diagnostic reagent for the quantitative determination of carbon dioxide in human serum and plasma

IMP/IVD/2023/000036 · from China
Bicarbonate Controls · Class BIMPORT · 2026-05-04

The Bicarbonate Controls are intended for performing quality control procedures with Biossays Bicarbonate (PEPC Enzymatic) assay when used for the quantitative determination of carbon dioxide(CO2).

IMP/IVD/2023/000036 · from China
Folate (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Folate (FA) in human serum, plasma and red blood cells.

IMP/IVD/2023/000036 · from China
Complement C4 (Immunoturbidimetric) · Class BIMPORT · 2026-05-04

The kit is an in vitro diagnostic reagent for the quantitative determination of Complement C4 (C4) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Free T3 (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Free T4 (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of free thyroxine (Free T4) in human serum and plasma.

IMP/IVD/2023/000036 · from China
PTH (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of biointact parathyroid hormone PTH(1?84) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Rev T3 (CLIA) · Class BIMPORT · 2026-05-04

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Rev T3 (rT3) in human serum and plasma.

IMP/IVD/2023/000036 · from China
Automatic Biochemistry Analyzer · Class AIMPORT · 2026-03-13

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2020/000184 · from China
Fully-auto chemiluminescence immunoassay analyzer · Class AIMPORT · 2026-03-13

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2020/000184 · from China
Fully-auto chemiluminescence immunoassay analyzer · Class AIMPORT · 2026-03-13

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2020/000184 · from China
Fully-auto chemiluminescence immunoassay analyzer · Class AIMPORT · 2026-03-13

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2020/000184 · from China
Fully-auto chemiluminescence immunoassay analyzer · Class AIMPORT · 2026-03-13

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2020/000184 · from China
?2-Microglobulin Calibrators · Class CIMPORT · 2026-02-17

The ?2-Microglobulin Calibrators are intended for performing the calibration procedures with Biossays® ?2-Microglobulin (Latex Immunoturbidimetric) when used for the quantitative determination of ?2-Microglobulin (?2-MG).

IMP/IVD/2023/000036 · from China
Lipoprotein (a) Calibrators · Class BIMPORT · 2026-02-17

The Lipoprotein (a) Calibrators are intended for performing the calibration procedures with Biossays Lipoprotein (a) (Latex Immunoturbidimetric) assay when used for the quantitative determination of Lipoprotein (a) (Lp (a)).

IMP/IVD/2023/000036 · from China
Transferrin Calibrator · Class BIMPORT · 2026-02-17

The Transferrin Calibrator is intended for performing the calibration procedures with Biossays Transferrin (Immunoturbidimetric) assay when used for the quantitative determination of Transferrin (TRF).

IMP/IVD/2023/000036 · from China
ISE Controls · Class BIMPORT · 2026-02-17

The ISE Controls are intended for performing quality control procedures with Biossays ISE Reagent Pack (ISE method) assay when used for the quantitative determination of K+, Na+, Cl-, iCa2+, Li+, pH (used for correction of iCa2+ only) in hu…

IMP/IVD/2023/000036 · from China
ISE Calibrators · Class BIMPORT · 2026-02-17

The ISE Calibrators are intended for establishing the calibration curve of the system with Biossays ISE Reagent Pack (ISE method) when used for the quantitative determination of K+, Na+, Cl-,iCa2+,Li+,pH (used for correction of iCa2+ only) …

IMP/IVD/2023/000036 · from China
ISE Reagent Pack (ISE method) · Class BIMPORT · 2026-02-17

The reagent pack is an in vitro diagnostic reagent for the quantitative determination of K+, Na+, Cl-, iCa2+, Li+, pH (used for correction of iCa2+ only) in human serum or whole blood and K+, Na+, Cl- in human urine.

IMP/IVD/2023/000036 · from China
Anti-Streptolysin O Calibrator · Class BIMPORT · 2026-02-17

The Anti-Streptolysin O Calibrator is intended for performing the calibration procedures with Biossays Anti-Streptolysin O (Latex) assay when used for the quantitative determination of ASO.

IMP/IVD/2023/000036 · from China
Electrolyte analyzer · Class AIMPORT · 2026-02-17

The automatic electrolyte analyzer is used to analyze the content of electrolyte ions in human samples.

IMP/IVD/2023/000036 · from China
Lipase (DGGMR Substrate) · Class BIMPORT · 2026-02-17

The kit is an in vitro diagnostic reagent for the quantitative determination of lipase (LIP) activity in human serum.

IMP/IVD/2023/000036 · from China
?1-Microglobulin Calibrators · Class CIMPORT · 2026-02-17

The ?1-Microglobulin Calibrators are intended for performing the calibration procedures with Biossays ?1-Microglobulin (Latex Immunoturbidimetric) assay when used for the quantitative determination of ?1-MG.

IMP/IVD/2023/000036 · from China
Automatic Biochemistry Analyzer · Class AIMPORT · 2026-02-09

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in a human sample

IMP/IVD/2023/000036 · from China
Fully auto chemiluminescence immunoassay analyzer · Class AIMPORT · 2026-02-09

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

IMP/IVD/2023/000036 · from China
Tip · Class AIMPORT · 2026-02-09

The Tip is an IVD accessory intended to be used with the MAGLUMI series Fully-auto Chemiluminescence Immunoassay Analyzer and Biolumi series Integrated System.

IMP/IVD/2023/000036 · from China
HIV Ab/Ag Combi (CLIA) · Class DIMPORT · 2026-02-06

The kit is an in vitro chemiluminescent immunoassay for the simultaneously qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1(Group M and Group O), HIV-2 in human serum and plasma using the MAGLUMI series Fully-auto chem…

IMP/IVD/2020/000184 · from China
Anti-HCV (CLIA) · Class DIMPORT · 2026-02-06

The kit is an In Vitro chemiluminescence immunoassay for the qualitative determination of Hepatitis C virus antibody (Anti-HCV) in human serum or plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi …

IMP/IVD/2020/000184 · from China
HBsAg (CLIA) · Class DIMPORT · 2026-02-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of HBsAg in human serum and plasma.

IMP/IVD/2020/000184 · from China
AFP (CLIA) · Class CIMPORT · 2025-11-21

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of AFP (Prenatal Screening) in human serum

IMP/IVD/2023/000036 · from China

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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