Domestic manufacturer · Goa · India

TULIP DIAGNOSTICS PRIVATE LIMITED

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
535
Manufacturing
456
Import
79
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices57
Class BLow–moderate risk292
Class CModerate–high risk72
Class D (high risk)Highest-risk devices114

CDSCO device licences

Anti-Fyb IgG Polyclonal Human IgG · Class DMFG · 2026-05-06

Matrix Polyclonal IgG sera is detection of Anti-Fyb antigen on human red blood cells by matrix gel system.

MFG/IVD/2021/000021
Anti-Fya IgG Polyclonal Human IgG · Class DMFG · 2026-05-06

Matrix Polyclonal IgG sera is detection of Anti-Fya antigen on human red blood cells by matrix gel system

MFG/IVD/2021/000021
Anti-Jkb IgM Monoclonal Human IgM · Class DMFG · 2026-05-04

Matrix monoclonal IgM sera is detection of Anti-Jkb antigen on human red blood cells by Matrix gel system.

MFG/IVD/2021/000021
Anti-Jka IgM Monoclonal Human IgM · Class DMFG · 2026-05-04

Matrix monoclonal IgM sera is detection of Anti-Jka antigen on human red blood cells by Matrix gel system.

MFG/IVD/2021/000021
Anti-P1 IgM Monoclonal Mouse IgM · Class DMFG · 2026-05-04

Matrix monoclonal IgM sera is detection of Anti-P1 antigen on human red blood cells by Matrix gel system

MFG/IVD/2021/000021
Anti-Lea IgM Monoclonal Mouse IgM · Class DMFG · 2026-05-04

Matrix monoclonal IgM sera is detection of Anti-Lea antigen on human red blood cells by matrix gel system

MFG/IVD/2021/000021
Anti-Cw IgM Monoclonal Human IgM · Class DMFG · 2026-04-27

Matrix monoclonal IgM sera is detection of Anti-Cw antigen on human red blood cells by matrix gel system

MFG/IVD/2021/000021
Anti-Dia IgG Polyclonal Human IgG · Class DMFG · 2026-04-27

Matrix Polyclonal IgG sera is detection of Anti-Dia antigen on human red blood cells by matrix gel system

MFG/IVD/2021/000021
Solubility Test for detection of Haemoglobin S in blood samples · Class CMFG · 2026-04-20

SICKLEVUE Solubility Test is a qualitative screening solubility test for the detection of haemoglobin S in blood samples

MFG/IVD/2021/000021
NT-proBNP Test Kit (Dry Fluorescence Immunoassay) · Class CIMPORT · 2026-04-10

NT-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 China
FT4 Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-04-10

FT4 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 China
cTnI Test Kit (Dry Fluorescence Immunoassay) · Class CIMPORT · 2026-04-10

cTnI 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 China
FT3 Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-04-10

FT3 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 China
D-Dimer Test Kit (Dry Fluorescence Immunoassay) · Class CIMPORT · 2026-04-10

D-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 China
Bovine Serum Albumin 22% Solution · Class CMFG · 2026-04-09

Bovine Serum Albumin is mainly used to enhance the reactivity of blood grouping and typing antibodies in direct agglutination tests.

MFG/IVD/2021/000021
Anti Human IgG (Monospecific Coombs Serum) · Class CMFG · 2026-04-09

Erybank Anti-Human IgG monospecific coombs reagent for direct and indirect antiglobulin Test.

MFG/IVD/2021/000021
Anti D IgG · Class DMFG · 2026-04-09

Eryclone 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/2021/000021
Anti-K (Kell) Monoclonal · Class DMFG · 2026-04-09

Eryclone 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/2021/000021
Control for Quality Control Procedures of D-Dimer Assays · Class CMFG · 2026-04-01

Turbodyne D-Dimer controls are useful for validating the calibration and performance of the respective Turbodyne D-Dimer reagents using Turbodyne SC analyser

MFG/IVD/2021/000021
Reagent Red Cells of Group O for ABO Reverse Grouping · Class DMFG · 2026-04-01

Matrix Erygen-O is 0.8% reagent red blood cells used for Reverse Grouping in Matrix gel cards

MFG/IVD/2021/000021
Reagent Red Cell Panel for Screening of Clinically significant antibodies · Class DMFG · 2026-04-01

Matrix 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/2021/000021
Quantitative Turbidimetric Immunoassay for Fibrinogen · Class CMFG · 2026-03-24

Quantia 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/2021/000021
Fibrinogen Control Level-I · Class CMFG · 2026-03-24

Seroquant 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/2021/000021
Quantitative Turbidimetric Immunoassay for D-Dimer · Class CMFG · 2026-03-17

Detection 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/2021/000021
TSH Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

TSH 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 China
TT3 Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

TT3 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 China
Progesterone Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

Progesterone 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 China
PCT Test Kit (Dry Fluorescence Immunoassay) · Class CIMPORT · 2026-03-16

PCT 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 China
PRL Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

PRL 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 China
TT4 Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

TT4 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 China
LH Test Kit (Dry Fluorescence Immunoassay) · Class BIMPORT · 2026-03-16

LH 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 China
IL-6 Test Kit (Dry Fluorescence Immunoassay) · Class CIMPORT · 2026-03-16

IL-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 China
Forward Grouping DAT Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
Forward Grouping Card with Anti D(VI+) · Class DMFG · 2026-03-12

According 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/2021/000021
Thromboplastin Reagent for Prothrombin Time (PT) Determination · Class CMFG · 2026-03-12

Liquiplastin 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/2021/000021
ABO Subgrouping Card Anti H · Class CMFG · 2026-03-12

Matrix 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/2021/000021
ABO/RhoD/AHG Neonate Group Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
Thromboplastin Reagent for Prothrombin Time (PT) Determination · Class CMFG · 2026-03-12

Uniplastin 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/2021/000021
ABO/Rho(D) Forward Grouping Confirmation Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
Calcified Thromboplastin Reagent for Prothrombin Time (PT) Determination · Class CMFG · 2026-03-12

Lyoplastin-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/2021/000021
Direct Antiglobulin Test Card · Class DMFG · 2026-03-12

Matrix Direct Antiglobulin test card is for detection and differentiation of IgG and C3d activity for DAT positive samples in whole blood specimen.

MFG/IVD/2021/000021
Forward and Reverse Grouping Card with Autocontrol · Class DMFG · 2026-03-12

Matrix 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/2021/000021
Activated Cephaloplastin Reagent for Partial Thromboplastin Time (PTT) Determination · Class CMFG · 2026-03-12

Celin - 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/2021/000021
Neutral Gel Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
ABO Subgrouping Card Anti A1 · Class CMFG · 2026-03-12

Matrix 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/2021/000021
Activated Cephaloplastin Reagent for Partial Thromboplastin Time (PTT) Determination · Class CMFG · 2026-03-12

Liquicelin - 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/2021/000021
Quantitative Turbidimetric Immunoassay for D-Dimer · Class CMFG · 2026-03-12

Detection 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/2021/000021
Forward Grouping and Crossmatch Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
AHG Coombs Test Card · Class DMFG · 2026-03-12

Matrix 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/2021/000021
Blood Grouping Card for ABO Forward Grouping with Autocontrol · Class DMFG · 2026-03-12

Erycard 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/2021/000021

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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