FAQ (Frequently Asked Questions)

Which PCR tests does CONGEN offer for food analysis?

CONGEN offers PCR solutions for food analysis, including allergen detection, animal and plant species identification, detection of genetically modified organisms (GMOs), and detection of food-associated microorganisms.

Which PCR tests does CONGEN offer for clinical diagnostics?

CONGEN develops and manufactures molecular biological detection methods for various areas of clinical diagnostics. These include tests for respiratory diagnostics, gastrointestinal diagnostics, nosocomial infections, sexually transmitted infections, and periodontitis.

A particular focus is on multiplex real-time PCR methods, which enable multiple targets to be detected simultaneously in a single reaction.

Do CONGEN PCR kits work on my real-time PCR instrument?

CONGEN detection methods are designed for use on commonly available real-time PCR platforms. Depending on the PCR instrument, specific instrument settings and analysis parameters may be required.

If you provide us with the model of your real-time PCR instrument and the CONGEN test you are interested in, we can check whether the test is suitable for your platform.

Which PCR instruments are CONGEN kits compatible with?

CONGEN kits are designed to be compatible with as many commercially available real-time PCR instruments as possible. For example, CONGEN kits can be used on:

• Agilent AriaDx
• Agilent AriaMx
• Applied Biosystems^® 7500
• Applied Biosystems™ QuantStudio™ 5
• Bio Molecular Systems MIC
• Bio-Rad CFX96
• Bio-Rad CFX96 Dx
• Bio-Rad CFX96 Opus
• Qiagen Rotor-Gene Q
• R-Biopharm RIDA^®CYCLER
• Roche cobas^® z 480 Analyzer
• Roche LightCycler^® 480 II
• Roche LightCycler^® PRO

eingesetzt werden.

Corresponding information and instrument settings are available at www.congen.de/download/.
Which instruments have been validated or are suitable for a specific test can be found in the respective User Manual and product-specific information available at www.congen.de/eifu/ by entering the relevant article number..

Where are CONGEN PCR kits manufactured?

CONGEN is headquartered in Berlin-Buch /Germany and develops its molecular biological detection methods at its own site.

The company has been based at the Berlin-Buch science and technology campus since 1998. Development and production activities have been continuously expanded at this location.

How does CONGEN monitor the quality of its PCR tests?

CONGEN ensures the quality of its products through comprehensive quality management and controlled development, production, and testing processes.

The processes are monitored from the selection and delivery of raw materials through to the finished product. Detection methods are developed and verified in accordance with the requirements of applicable standards, customers, and the market. Clinical products are subject to the requirements of DIN EN ISO 13485. In addition, selected CE-certified tests are evaluated through participation in external proficiency testing programs.

Are CONGEN PCR tests validated?

Selected products have been validated by external organizations such as AOAC and MicroVal. PCR tests are identified accordingly both online and on the product itself. If you have any questions, please contact us at marketing@congen.de.

Which quality standards does CONGEN comply with?

CONGEN is certified according to DIN EN ISO 9001 and DIN EN ISO 13485.

ISO 9001 specifies requirements for a quality management system. ISO 13485 is specifically designed for quality management systems for medical devices.

CONGEN has many years of experience working in accordance with these quality standards.

Is CONGEN certified as a medical device manufacturer?

CONGEN was first certified according to ISO 13485 in 2013 for the development, manufacture, and distribution of molecular biological test.

Where can I order CONGEN products?

SureFast® products for microbiology and clinical diagnostics can be ordered directly from CONGEN. Please use our contact form: Contact CONGEN. If you need assistance selecting the appropriate detection method, the CONGEN team will be happy to help.

All detection methods from the SureFood®, RIDA®GENE, and RIDA®UNITY product lines can be ordered directly from our distribution partner: R-Biopharm.

Who distributes CONGEN kits?

CONGEN products are distributed worldwide through our distribution partner R-Biopharm. This includes the SureFood®, SureFast®, RIDA®GENE, and RIDA®UNITY product lines.

Would you like to become a distribution partner for real-time PCR diagnostics for our SureFast® series? Please contact us at marketing@congen.de.

Are CONGEN PCR kits available immediately?

For specific information regarding product availability and delivery times, please contact the responsible distribution partner or CONGEN directly. For a specific product inquiry, our team can provide you with the appropriate contact.

Please email us at marketing@congen.de.

Where can I find the User Manual for a CONGEN kit?

Customers can download the User Manual and product-specific updates (Yellow Notes) directly from the electronic instructions for use (eIFU) section at www.congen.de/eifu/.

CONGEN also provides information on instrument settings and data analysis in the download section: www.congen.de/en/downloads/

Where can I find the quality certificate for my kit?

The lot-specific Quality Assurance Certificate (QAC), applicable Safety Data Sheets (MSDS), and Transport Certificates are available in the electronic instructions for use (eIFU) section at www.congen.de/eifu/.

Where can I find the technical documents for a CONGEN product?

Technical documents for CONGEN products are available for download in the Electronic Instructions for Use (eIFU) section at https://www.congen.de/en/eifu/

These include, among other documents, User Manuals, Quality Assurance Certificates (QAC), Safety Data Sheets (MSDS), and Yellow Notes.

How do I file a complaint about a CONGEN PCR kit?

Please use our online contact form to submit complaints: Contact form

For efficient processing, please provide the delivery note and/or product name, article number, lot number, and, if possible, a detailed description of the problem.

For complaints concerning the SureFood®, RIDA®GENE, and RIDA®UNITY product lines, please contact our distribution partner R-Biopharm directly at sales@r-biopharm.de.

What can I do if I have a problem with a CONGEN product?

If you experience any problems or have questions regarding a detection method, please contact us directly via our contact form: Contact form or by email at marketing@congen.de.

For efficient support, please describe the problem as precisely as possible and, if available, provide additional information such as images or test results.

Does CONGEN develop customized PCR tests?

Yes. CONGEN develops customized PCR-based detection methods for individual analytical questions and customer requirements.

Can CONGEN develop a PCR assay according to my requirements?

Yes. Development may include, for example, DNA or RNA detection, multiplex real-time PCR, different sample matrices, or adaptation to customer-specific formats.

The scope of a development project is determined individually based on the analytical requirements and the desired end product.

How does CONGEN develop a customized PCR test?

A customized development project at CONGEN begins with defining the analytical question and the requirements for the detection method. Based on these requirements, CONGEN develops the appropriate PCR method and verifies its performance.

Depending on the application, this may include multiplex PCR, different sample matrices, DNA or RNA detection, and customer-specific formats.

What steps are involved in customized PCR development?

CONGEN can support development projects from initial concept through development and verification to implementation in a customized test format.

CONGEN operates according to high quality standards and in compliance with the requirements of ISO 9001 and ISO 13485 for medical devices.

The specific process, timeline, and scope of the project are agreed individually.

Does CONGEN specialize in multiplex real-time PCR?

The development of multiplex and highly multiplexed real-time PCR methods is one of CONGEN‘s core areas of expertise. We develop PCR assays in accordance with customer-specific and market-relevant requirements.

Does CONGEN develop multiplex PCR assays?

CONGEN develops multiplex PCR assays in which multiple target parameters can be detected simultaneously in a single PCR reaction.

Our focus is on PCR assays for food analysis, clinical diagnostics, and point-of-care applications. 

How experienced is CONGEN in developing multiplex PCR?

CONGEN has more than 25 years of experience in the development and verification of real-time PCR methods and has completed more than 300 development projects.