Domestic manufacturer · Gujarat · India

Nucleus Diagnosys LLP

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.

CDSCO licences

974

Manufacturing

973

Import

1

FDA clearances

0

Risk-class mix (CDSCO)

Class A (low risk)	Lowest-risk devices	87
Class B	Low–moderate risk	816
Class C	Moderate–high risk	63
Class D (high risk)	Highest-risk devices	8

CDSCO device licences

Diagnostics test reagent/ kits for PT · Class CMFG · 2026-03-12

Intended for the estimation of prothrombin time in plasma/body fluids.

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for APTT · Class CMFG · 2026-03-12

Intended for the estimation of Activated Partial Thromboplastin Time in plasma/body fluids.

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for ASO · Class CMFG · 2026-03-12

Use for determination of ASO in human serum

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for Antistreptolysin O (ASO) Control · Class CMFG · 2026-01-14

Use detection of Antistreptolysin O (ASO) in human serum or plasma

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for RF, ASO and CRP Calibrator · Class CMFG · 2026-01-14

Use detection of RF, ASO and CRP in human serum or plasma

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for Antistreptolysin O (ASO) Calibrator · Class CMFG · 2026-01-14

Use detection of Antistreptolysin O (ASO) in human serum or plasma

MFG/IVD/2019/000026

Diagnostics test reagent/ kits for RF, ASO and CRP Control · Class CMFG · 2026-01-14

Use detection of RF, ASO and CRP in human serum or plasma

MFG/IVD/2019/000026

D Dimer (Immunoturbidimetric Method) · Class CMFG · 2025-11-21

D-dimer tests are intended to use to detect the presence of an inappropriate blood clot (thrombus). Some of the conditions that the D-dimer test is used to help rule out include: Deep vein thrombosis (DVT) Pulmonary embolism (PE).

MFG/IVD/2019/000026

Allergens test reagents/kits - Spices - Green Pepper · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Screen Perennial (d1, e1, e5, m3) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - White Pepper · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Multi Screen (g6, g12, t3, w6, d1, e1, e5, m2) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Curcuma · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Tarragon · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Ginger · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices -Cinnamon · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Basil · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices -Origan · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices -Black Pepper · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 16 (s1, s2, s3, s6, f47) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Pollen / Molds (m3, m6, g12, g15) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Screen Multi 10 (e1, e5, d1, d3, m2, m3) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Regional Mix (g6, w6, w9, w21, t3) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Inhalation Panel (t1, t8, t17, t28, w20, b14, b23, m22, m36) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 5 (s5, s6, s7) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Screen Seasonal (g6, t3, w6, m6) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Piment · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Mace · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Red Pepper · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Cardamom · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Thyme · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Sage · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Clove · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Chives · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Juniper Berry · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Coriander · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Chili · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Marjoram · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 4 (s1, s2, s3) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Inhalation Mix (d1, d2, ex6,e1, e5, m2, m3, m6) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Occupational -Azorubin · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 71 (s3, s5, s16, s28) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 2 (s4, s6, s7, f89) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 3 (s5, s6, s7, f79) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Spices 1 (s1, s2, s3, f47) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Screen Multi 32 (d1, d2, e1, e5, g6, t3, t14, w6, w15, m6) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Beanstalk · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Inhalation Panel (d2, e1, e3, e5, m6) · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices - Food Panel (f7, f18, f29, f38, f48, f51, f65, f70, f88). · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

Allergens test reagents/kits - Spices -Lovage · Class BMFG · 2025-11-16

Specific IgE test reagent / kit is a medical device intended for the estimation of allergens in blood/body fluids for allergens.

MFG/IVD/2019/000007 · Gujarat

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.

Early access

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