TULIP DIAGNOSTICS PRIVATE LIMITED
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 57 |
| Class B | Low–moderate risk | 292 |
| Class C | Moderate–high risk | 72 |
| Class D (high risk) | Highest-risk devices | 114 |
CDSCO device licences
Matrix Polyclonal IgG sera is detection of Anti-Fyb antigen on human red blood cells by matrix gel system.
MFG/IVD/2021/000021Matrix Polyclonal IgG sera is detection of Anti-Fya antigen on human red blood cells by matrix gel system
MFG/IVD/2021/000021Matrix monoclonal IgM sera is detection of Anti-Jkb antigen on human red blood cells by Matrix gel system.
MFG/IVD/2021/000021Matrix monoclonal IgM sera is detection of Anti-Jka antigen on human red blood cells by Matrix gel system.
MFG/IVD/2021/000021Matrix monoclonal IgM sera is detection of Anti-P1 antigen on human red blood cells by Matrix gel system
MFG/IVD/2021/000021Matrix monoclonal IgM sera is detection of Anti-Lea antigen on human red blood cells by matrix gel system
MFG/IVD/2021/000021Matrix monoclonal IgM sera is detection of Anti-Cw antigen on human red blood cells by matrix gel system
MFG/IVD/2021/000021Matrix Polyclonal IgG sera is detection of Anti-Dia antigen on human red blood cells by matrix gel system
MFG/IVD/2021/000021SICKLEVUE Solubility Test is a qualitative screening solubility test for the detection of haemoglobin S in blood samples
MFG/IVD/2021/000021NT-proBNP Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of NT-proBNP (N-terminal Brain Natriuretic Peptide Precursor) in human serum and plasma.
IMP/IVD/2025/000152 · from ChinaFT4 Test Kit (Dry Fluorescence Immunoassay) can be used to diagnose hypothyroidism and hyperthyroidism. It is suitable for In-vitro quantitative detection of free thyroxine content in human serum and plasma.
IMP/IVD/2025/000152 · from ChinacTnI Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of cTnI (Cardiac Troponin I) in human serum and plasma. This test is used as an aid in the diagnosis of myocardial injury such as Acute Myocardia…
IMP/IVD/2025/000152 · from ChinaFT3 Test Kit (Dry Fluorescence Immunoassay) can be used to diagnose hypothyroidism and hyperthyroidism. It is suitable for In-vitro quantitative detection of free triiodothyronine content in human serum and plasma.
IMP/IVD/2025/000152 · from ChinaD-Dimer Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of D-Dimer in human fingertip blood. This test is used as an aid in the assessment and evaluation of patients suspected of deep vein thrombosi…
IMP/IVD/2025/000152 · from ChinaBovine Serum Albumin is mainly used to enhance the reactivity of blood grouping and typing antibodies in direct agglutination tests.
MFG/IVD/2021/000021Erybank Anti-Human IgG monospecific coombs reagent for direct and indirect antiglobulin Test.
MFG/IVD/2021/000021Eryclone Anti-D (IgG) is a monoclonal IgG reagent for Rho (D) typing used for Rho (D) typing reagent for slide and tube tests and is 100% specific to Rho(D) antigen in whole blood specimens.
MFG/IVD/2021/000021Eryclone Anti-K reagent can be used to detect the presence of K antigen on red blood cells for phenotyping and blood transfusion purpose.
MFG/IVD/2021/000021Turbodyne D-Dimer controls are useful for validating the calibration and performance of the respective Turbodyne D-Dimer reagents using Turbodyne SC analyser
MFG/IVD/2021/000021Matrix Erygen-O is 0.8% reagent red blood cells used for Reverse Grouping in Matrix gel cards
MFG/IVD/2021/000021Matrix Erygen-AS Screen Cell I II III is 0.8% red blood cell suspension used for Antibody Screening and Identification in Matrix gel cards
MFG/IVD/2021/000021Quantia Fibrinogen is used in evaluating patients with a risk of atherosclerotic disease due to high fibrinogen levels. Low fibrinogen levels are observed in patients with liver disease, disseminated intravascular coagulation (DIC).
MFG/IVD/2021/000021Seroquant range of controls are assayed controls useful for monitoring the precision of laboratory testing procedures. Seroquant controls are also useful for validating the calibration and performance of the respective reagents using a turb…
MFG/IVD/2021/000021Detection of D-Dimer is invaluable as a diagnostic marker for thrombotic conditions such as DIC, DVT and PE. D-Dimer levels can also be used to monitor thrombolytic therapy with t-PA and with streptokinase, thrombotic complications in pregn…
MFG/IVD/2021/000021TSH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of TSH (Thyroid stimulating hormone) in human serum and plasma.
IMP/IVD/2025/000152 · from ChinaTT3 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total TT3 (Triiodothyronine) in human serum and plasma under normal physiological conditions, total TT3 only accounts for about 5% of thyroid h…
IMP/IVD/2025/000152 · from ChinaProgesterone Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of Progesterone in serum and plasma. Progesterone is the main biological active progesterone secreted by the ovary, known for progesteron…
IMP/IVD/2025/000152 · from ChinaPCT test kit (Dry Fluorescence Immunoassay) is intended for the in vitro quantitative determination of PCT (Procalcitonin) in serum and plasma. This test is used as an aid in the differential diagnosis of bacterial infection and viral infec…
IMP/IVD/2025/000152 · from ChinaPRL Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of PRL (prolactin) in serum. Clinically, it is mainly used to evaluate the endocrine function of pituitary gland.
IMP/IVD/2025/000152 · from ChinaTT4 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total TT4(Thyroxine) in human serum and plasma under normal physical conditions. It can be used in the monitoring of hyperthyroidism and hypoth…
IMP/IVD/2025/000152 · from ChinaLH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of luteinizing hormone in serum. Clinically, it is mainly used to test whether a woman ovulates, screen the causes of infertility or early abortion…
IMP/IVD/2025/000152 · from ChinaIL-6 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of IL-6 (Interleukin-6) in human serum and .IL-6 can be synthesized by a variety of cells, including activated T cells and B cells, Mononuclear-M…
IMP/IVD/2025/000152 · from ChinaMatrix Forward Grouping DAT Card is for detection of ABO and Rho (D) blood group systems using two different clones of Anti-D in separate microtubes and Direct Coombs test (DAT) in whole blood specimen.
MFG/IVD/2021/000021According to ABO blood group system, human red blood cell antigen can be divided into four groupsA,B,AB and O depending on the presence or absence of corresponding antigens on the red blood cells.
MFG/IVD/2021/000021Liquiplastin is liquid stable, ready to use Thromboplastin reagent, for the Prothrombin Time (PT) determination in plasma, monitoring Oral Anticoagulant therapy and assessment of Extrinsic Pathway. The reagent is derived from rabbit brain.
MFG/IVD/2021/000021Matrix ABO Subgrouping Card Anti-H is for detection of H antigen on red cells in whole blood specimen. It is qualitative, screening test used for in vitro Diagnostics only
MFG/IVD/2021/000021Matrix ABO/Rho (D)/AHG Neonate Group Card is used for the determination of ABO and Rho (D) status and direct coombs test of neonates. Contains monoclonal Anti-A, Anti-B, Anti-A,B Anti-D (VI-) and polyspecific coombs.
MFG/IVD/2021/000021Uniplastin is a novel, highly sensitive, low opacity, ready to use Calcified Thromboplastin Reagent, for Prothrombin Time (PT) determination in plasma, monitoring Oral Anticoagulant Therapy and assessment of Extrinsic pathway. Uniplastin is…
MFG/IVD/2021/000021Matrix ABO & Rho (D) Forward grouping card is used for detecting the Forward group and type of human blood according to the ABO / Rho (D) system
MFG/IVD/2021/000021Lyoplastin-LS is liquid stable, ready to use Thromboplastin reagent, for the Prothrombin Time (PT) determination in plasma, monitoring Oral Anticoagulant therapy and assessment of Extrinsic Pathway. The reagent is derived from rabbit brain.
MFG/IVD/2021/000021Matrix Direct Antiglobulin test card is for detection and differentiation of IgG and C3d activity for DAT positive samples in whole blood specimen.
MFG/IVD/2021/000021Matrix ABO / Rho (D) Forward and Reverse Grouping Card with Autocontrol is used for determination of ABO and Rho (D) blood group systems and reverse grouping for confirmation of ABO grouping. Contains monoclonal Anti-A, Anti-B and Anti-D (V…
MFG/IVD/2021/000021Celin - SE, a ready to use liquid stable reagent, for the Activated Partial Thromboplastin Time (APTT) determination in plasma, monitoring of heparin therapy and assessment of Intrinsic pathway The reagent is derived from soyabean cephalopl…
MFG/IVD/2021/000021Matrix Neutral Gel Card is used for saline and enzyme phase tests including antibody screening, antibody identification, compatibility testing and ABO Reverse Grouping. Contains neutral gel.
MFG/IVD/2021/000021Matrix ABO Subgrouping Card Anti-A1 is for the confirmation of A1 subgroup of A in whole blood specimen. It is qualitative, screening test used for in vitro Diagnostics only.
MFG/IVD/2021/000021Liquicelin - E ready to use liquid stable, Cephaloplastin reagent, for the Activated partial thrombin time (APTT) determination in plasma for monitoring of heparin therapy and assessment of Intrinsic pathway. The reagent is derived from rab…
MFG/IVD/2021/000021Detection of D-Dimer is invaluable as a diagnostic marker for thrombotic conditions such as DIC, DVT and PE. D-Dimer levels can also be used to monitor thrombolytic therapy with t-PA and with streptokinase, thrombotic complications in pregn…
MFG/IVD/2021/000021Matrix Forward grouping and crossmatch card is used for confirmation of ABO and Rho (D) blood group systems for both patient and donor, ABO and Rho (D) compatibility testing, major crossmatch in coombs and enzyme phase along with coombs pha…
MFG/IVD/2021/000021Matrix AHG (Coombs) Test Card is used for direct coombs test (DAT) and indirect coombs tests (IAT) including antibody screening, antibody identification and compatibility testing. Contains polyspecific coombs reagent
MFG/IVD/2021/000021Erycard ABO is a blood grouping card for ABO Forward Grouping with Autocontrol. It can be used for donor's blood group screening in outdoor camps as well as in blood banks.
MFG/IVD/2021/000021Global 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.