Export Snapshot

Minimum order

1000 Numbers

HSN Code

901890

Origin

India

Lead time

On request

Port of dispatch

On request

Packaging

Standard export packaging

Shelf life / storage

As per product specification

Export markets served

AO BW LR NP ZM

Ability to customise

As per OEM brief

Values shown are for Labgene Bio-Tech Private Limited.

MDR 2017 and ISO13485:2016

Company Labgene Bio-Tech Private Limited

Labgene Bio-Tech Private Limited

Labgene Biotech is a leading Indian manufacturer at the forefront of IVD product development. We operate an ISO 13485-certified, WHO-GMP, and USFDA-compliant facility, with all processes driven by hundreds of validated SOPs. Our R&D team has developed over 200 diagnostic tests, with 30+ currently in active use across chain laboratories, government platforms (GEM Portal), private distributors, and international export markets.

Registered address: Mahesana, India. Industry: Healthcare, Medical Supplies & Pharmaceuticals › Biotechnology.

FIEO Registered

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Established

2019

Employees

51–100

GST

24AADCL8897L1ZQ

IEC code

AADCL8897L

Export markets

AO BW LR NP ZM

Member since

Jul 2025

Turnover

$2 MM - $5 MM

Incorporation type

On request

MDR 2017 and ISO13485:2016

Product details

The Labgene H. pylori Antibody Combo Rapid Test Kit is a reliable lateral flow immunoassay designed for the detection of antibodies (IgG, IgM, and IgA) against Helicobacter pylori. This bacterium is strongly associated with gastritis, gastric and duodenal ulcers, chronic indigestion, and in severe cases, gastric cancer.

The test enables early and accurate screening of H. pylori infections with a simple procedure that provides clear results in 20 minutes. It is intended for professional in-vitro diagnostic use and requires no specialized equipment, making it an excellent choice for hospitals, diagnostic laboratories, and clinics.

• Detects IgG, IgM, and IgA antibodies to H. pylori
• Result time: 15–20 minutes
• Sample types: Whole blood, serum, plasma
• Accuracy: 98–100% sensitivity & specificity
• Pack size: 25 Tests/Box
• Storage conditions: 2°C – 30°C
• Easy-to-use, no additional instruments required

Description provided by Labgene Bio-Tech Private Limited.

IgG, IgM, IgA antibodies against Helicobacter pylori

15–20 minutes

Whole blood, serum, or plasma

98% to 100%

One-step lateral flow immunoassay

25 Tests per Box

2°C to 30°C

No specialized equipment required

Professional in-vitro diagnostic testing

Hospitals, diagnostic labs, clinics

Specifications

Test Principle

Lateral flow immunoassay

Antibody Detection

Qualitative detection of IgG, IgM, IgA

Sample Volume

Small sample volume of blood, serum, or plasma

Results Interpretation

Visual qualitative result (presence or absence of antibodies)

Kit Contents

Test devices, buffer, lancets (optional), instructions

Shelf Life

Typically 12 months (subject to manufacturer)

Room Temperature Stability

2°C to 30°C

Time to Use After Sample Application

15-20 minutes

Manufacturing Standard

Complies with professional IVD standards

Use cases

Category

Medical Diagnostics > Infectious Disease Tests > Helicobacter Pylori Test Kits

Primary application

Brand

labgene

Product type

Product

Logistics & handling

Lead time

On request

Packaging

As per buyer requirement

Storage condition

As recommended by supplier

Origin

India

Form

As listed by supplier

Commercials Labgene Bio-Tech Private Limited

Minimum order

1000 Numbers

Lead time

On request

Payment terms

As per negotiated commercial agreement

Frequently asked by buyers

Can the Labgene H.Pylori Antibody Rapid Test Kit differentiate between acute and past infections?

Yes, by detecting IgM (indicative of recent or acute infection), along with IgG and IgA antibodies, the test provides a broader antibody profile that helps clinicians assess whether the infection is acute or chronic/past.

Is specialized lab equipment required to perform this test?

No, the Labgene H.Pylori Rapid Test Kit is a one-step lateral flow immunoassay that requires no specialized instruments, making it suitable for point-of-care or laboratory use in diverse clinical settings.

What sample types are compatible with this rapid test kit?

The test supports analysis using whole blood, serum, or plasma samples, allowing flexibility based on available specimen types.

How does storage temperature impact the test performance?

The test kit is stable and designed to perform optimally when stored between 2°C and 30°C, ensuring reliable results within this temperature range.

What is the total number of tests supplied in one package?

Each box contains 25 individual test kits, suitable for multiple patients or batch testing applications.

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