Export Snapshot

Minimum order

1000 Numbers

HSN Code

901890

Origin

India

Lead time

On request

Port of dispatch

On request

Packaging

Individually sealed test cassettes

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

View profile →

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 MAI hCG Pregnancy Rapid Test Kit provides an accurate and user-friendly solution for early pregnancy detection. Designed in a maxi-size cassette format for easy handling, it uses a dual-antibody system for high specificity and accuracy, with no cross-reactivity.

• Detects hCG at 25 mIU/mL for early pregnancy diagnosis
• Delivers results in 1–5 minutes
• Uses a dual-antibody system (monoclonal & polyclonal)
• 100% sensitivity & specificity in internal and external validations
• No cross-reactivity with LH, FSH, or TSH
• Clear, easy-to-read pink/red lines for test and control results
• Stable at 2°C – 30°C, no refrigeration required
• Simple urine-based test, no fasting needed

Description provided by Labgene Bio-Tech Private Limited.

25 mIU/mL for early pregnancy detection

Results available within 1 to 5 minutes

Maxi cassette design for easy handling and clear results

Dual-antibody system with monoclonal and polyclonal antibodies

100% sensitivity and specificity in internal and external validations

No cross-reactivity with LH, FSH, or TSH hormones

Clear pink/red colored lines for test and control results

Stable at 2°C to 30°C, no refrigeration required

Urine-based sample, no fasting required

For professional use in clinical and laboratory environments

Specifications

Test Type

Qualitative immunochromatographic urine test

Analyte Detected

Human chorionic gonadotropin (hCG)

Sensitivity Threshold

25 mIU/mL

Result Display Time

1–5 minutes

Antibody Types

Monoclonal and Polyclonal

Cross-reactivity Tested Against

LH, FSH, TSH

Storage Temperature Range

2°C to 30°C

Test Sample

Urine

Test Format

Maxi cassette

Packaging

Individually sealed test cassettes

Use cases

Category

Medical Diagnostics > Pregnancy Tests > Urine Pregnancy Test Kits

Primary application

Brand

Not specified

Product type

Product

Logistics & handling

Lead time

On request

Packaging

Individually sealed test cassettes

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

What is the minimum hCG level that the MAI Pregnancy Rapid Test Kit can detect?

The MAI Pregnancy Rapid Test Kit can detect hCG concentrations as low as 25 mIU/mL, allowing for early pregnancy detection.

Does the MAI Pregnancy Rapid Test Kit require any special storage conditions?

No refrigeration is required; the test kit remains stable between 2°C to 30°C, making storage and transportation convenient.

Is there any possibility of cross-reactivity with other hormones in this test?

The test uses a dual-antibody system specifically designed to avoid cross-reactivity with hormones like LH, FSH, or TSH, ensuring accurate results.

How quickly can healthcare professionals expect results after testing with the MAI kit?

Results are available rapidly within 1 to 5 minutes after urine sample application.

Can this test be used outside of clinical settings, such as in field diagnostics?

Yes, the maxi cassette format and stable storage conditions without refrigeration enable professional use in diverse environments including clinics, hospitals, and field diagnostics.

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