Reckon Diagnostics Private Limited

Reckon Diagnostics Private Limited, established on October 29, 1984, is a privately held company headquartered in Vadodara, Gujarat, India. The company specializes in the manufacturing of in vitro diagnostic products, including clinical chemistry reagents, serology kits, rapid diagnostic tests, and diagnostic instruments. With over 30 years of experience, Reckon Diagnostics has developed a strong presence in the diagnostic industry.

The company operates with an authorized capital of ₹2.50 crore and a paid-up capital of ₹2.50 crore. As of April 4, 2024, Reckon Diagnostics employed approximately 200 professionals. The leadership team includes Nital Mahendrakumar Patel, serving as the Managing Director since January 1, 1999, and Payal Nital Patel, the Whole-Time Director since January 15, 2008.

Reckon Diagnostics operates a state-of-the-art manufacturing facility in Vadodara, Gujarat, covering an area of 30,000 square feet. This facility is designed to meet stringent Good Manufacturing Practices (GMP) standards, ensuring the production of high-quality diagnostic products. The plant specializes in the production of clinical chemistry reagents, serology kits, rapid diagnostic tests, and diagnostic instruments, catering to both domestic and international markets.

The leadership team at Reckon Diagnostics Private Limited comprises:

• Nital Mahendrakumar Patel: Managing Director since January 1, 1999.

• Payal Nital Patel: Whole-Time Director since January 15, 2008.

These leaders have been instrumental in steering the company towards its current position in the diagnostic industry.

Reckon Diagnostics Private Limited has made significant strides in regulated markets, particularly in the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained necessary regulatory approvals and certifications, including ISO 13485:2016 and GMP certifications, which are essential for market access in these regions. These certifications demonstrate the company's commitment to maintaining high-quality standards in its manufacturing processes.

Reckon Diagnostics has expanded its presence in emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, such as ISO 13485:2016 and GMP, has facilitated its entry into these markets. By obtaining WHO prequalification, Reckon Diagnostics has enhanced its credibility and marketability in these regions, enabling access to a broader customer base.

Reckon Diagnostics has strategically diversified its geographic footprint to mitigate concentration risks. The company's operations span across India and extend to various international markets, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. This diversification strategy allows Reckon Diagnostics to leverage growth opportunities in multiple regions while reducing dependency on any single market.

Reckon Diagnostics Private Limited has registered its manufacturing facility with the U.S. Food and Drug Administration (FDA), a critical step for exporting diagnostic products to the United States. The company has also filed Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) with the FDA, facilitating the approval process for its products. Reckon Diagnostics maintains a history of successful FDA inspections, reflecting its commitment to adhering to stringent regulatory standards.

Reckon Diagnostics holds WHO prequalification, which is essential for supplying diagnostic products to international organizations and various countries. The company has also obtained EU GMP certificates, ensuring compliance with European manufacturing standards. These certifications underscore Reckon Diagnostics' dedication to producing high-quality diagnostic products that meet global standards.

In India, Reckon Diagnostics Private Limited has secured manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), authorizing it to produce diagnostic products for the domestic market. The company has obtained approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating its export activities. These regulatory approvals demonstrate Reckon Diagnostics' compliance with Indian pharmaceutical regulations.

As of March 28, 2026, Reckon Diagnostics Private Limited has maintained a clean regulatory record, with no Form 483 observations, warning letters, or import alerts issued by regulatory authorities. This indicates the company's consistent adherence to regulatory standards and its commitment to quality in manufacturing processes.

In the diagnostic products sector, Reckon Diagnostics Private Limited faces competition from both domestic and international companies. Key competitors include multinational corporations and established Indian firms specializing in diagnostic reagents and instruments. Reckon Diagnostics differentiates itself through its extensive experience, adherence to international quality standards, and a comprehensive product portfolio. While specific market share data is not available, the company's strategic focus on quality and customer satisfaction positions it favorably in the competitive landscape.

Reckon Diagnostics' key differentiators include its over 30 years of experience in the diagnostic industry, a comprehensive product portfolio encompassing clinical chemistry reagents, serology kits, rapid diagnostic tests, and diagnostic instruments, and a strong commitment to quality, evidenced by ISO 13485:2016 and GMP certifications. The company's focus on customer satisfaction and continuous product development further enhances its competitive edge.

Reckon Diagnostics Private Limited is strategically positioned as a manufacturer and exporter of diagnostic products, focusing on both domestic and international markets. The company's future outlook includes expanding its product offerings, enhancing research and development capabilities, and strengthening its presence in emerging markets. By leveraging its experience and commitment to quality, Reckon Diagnostics aims to achieve sustainable growth and maintain its position as a leading player in the diagnostic industry.

Reckon Diagnostics Private Limited has demonstrated a consistent track record in manufacturing and exporting diagnostic products. The company's export volume and consistency are supported by its adherence to international quality standards and certifications. Reliability indicators include a clean regulatory record and a strong focus on customer satisfaction. These factors contribute to Reckon Diagnostics' reputation as a dependable supplier in the diagnostic products sector.

Importers should verify the following certifications when considering Reckon Diagnostics Private Limited as a supplier:

• FDA Registration: Confirm the company's registration with the U.S. Food and Drug Administration to ensure compliance with U.S. regulations.

• WHO Prequalification: Verify the company's prequalification status with the World Health Organization to ensure product quality and safety.

• EU GMP Certificate: Check for the company's certification under the European Union's Good Manufacturing Practice standards.

• ISO 13485:2016 Certification: Ensure the company holds this certification, indicating compliance with international quality management standards for medical devices.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting Reckon Diagnostics directly.

When conducting due diligence on Reckon Diagnostics Private Limited, consider the following steps:

• Verify Regulatory Certifications: Confirm the validity of FDA registration, WHO prequalification, EU GMP certificate, and ISO 13485:2016 certification.

• Assess Financial Health: Review the company's financial statements for the latest fiscal year to evaluate profitability, liquidity, and overall financial stability.

• Evaluate Manufacturing Capabilities: Inspect the manufacturing facility to ensure it meets required standards and is capable of fulfilling order volumes.

• Review Quality Assurance Processes: Examine the company's quality management system to ensure adherence to international quality standards.

• Check References and Reputation: Seek feedback from existing clients and partners to assess the company's reliability and reputation in the industry.

Be cautious of any discrepancies in certification validity, financial irregularities, or negative feedback from clients, as these may indicate potential risks.