The questions we are asked most often about our products, analyzer compatibility, documents and partnership. If you cannot find your answer here, write to us.
Archem offers a comprehensive IVD portfolio covering reagents, controls & calibrators, and diagnostic analyzers.
Our reagent portfolio includes clinical chemistry reagents, HbA1c HPLC solutions, hematology reagents, ISE reagents, and cleaners & buffer solutions. We also provide quality control and calibration materials, together with clinical chemistry, hematology and HbA1c analyzers through our group portfolio.
Explore Our Products
You can find compatible clinical chemistry reagents by checking your analyzer manufacturer and model in our Compatibility Chart. Archem provides dedicated and open-system reagent solutions for a wide range of clinical chemistry analyzer platforms.
If your analyzer or required assay is not listed, our technical team can evaluate your specific reagent and application requirements.
View Compatibility Chart
Archem clinical chemistry reagents support a wide range of automated, semi-automated and open-system analyzers. Dedicated reagent configurations are available for selected platforms from manufacturers including Abbott, Beckman Coulter/Olympus, Dirui, Erba, Mindray, Roche, Siemens, Thermo Fisher, Tokyo Boeki and others.
Compatibility varies by reagent and analyzer model. For detailed information, please check our Compatibility Chart or contact our technical team.
Dedicated reagents are configured for specific analyzer platforms, with reagent packaging, volumes and application parameters adapted to the requirements of the relevant system.
Open-system reagents provide greater flexibility and are designed for use with compatible open and semi-automated clinical chemistry analyzers using the appropriate application parameters.
Explore Dedicated ReagentsExplore Open-System Reagents
Dedicated clinical chemistry reagents are reagent configurations developed for specific analyzer platforms. Depending on the system, they may include analyzer-specific packaging, reagent volumes and application parameters designed to support efficient implementation and reliable performance.
Archem provides dedicated reagent solutions for a range of leading clinical chemistry analyzer platforms.
Explore Dedicated Reagents
Yes. Application parameters are available for selected compatible analyzer platforms, and Archem provides technical support for reagent implementation and application optimization.
If you require an application for a specific analyzer model, contact our technical team with the analyzer and reagent information so that availability can be evaluated.
Contact Technical Support
Yes. Archem provides OEM manufacturing solutions for IVD reagents, supporting diagnostic companies and business partners with manufacturing, filling, packaging and project-specific requirements.
Our OEM capabilities cover a broad range of reagent solutions and can be evaluated according to the product, target market and project requirements.
Explore OEM Solutions
Yes. Archem offers private-label IVD reagent solutions for companies looking to market products under their own brand. Depending on the project, solutions can include customized labeling, packaging and product configurations.
Our team works with partners to define the appropriate private-label model based on their portfolio and market requirements.
Discuss Your Private Label Project
Yes. Archem supplies bulk clinical chemistry reagents for diagnostic companies that perform their own filling, packaging or private-label operations.
Bulk supply requirements, volumes and product configurations are evaluated according to the individual project.
Explore Bulk Reagent Solutions
OEM manufacturing refers to manufacturing products according to an agreed business and product specification. Private label allows products to be supplied for commercialization under the partner's own brand, while bulk supply provides reagents in larger volumes for partners that manage their own filling, packaging or downstream operations.
Archem can support different cooperation models depending on the partner's manufacturing capabilities and market requirements.
Explore OEM & Bulk Solutions
Yes. Packaging, labeling and pack-size requirements can be evaluated as part of an OEM or private-label project. Available configurations depend on the product, analyzer platform, production requirements and project scope.
Our team works with partners to determine a suitable configuration for their target market and commercial requirements.
Discuss Your Project
To start an OEM or private-label IVD project, contact our team with information about the products you are interested in, your target market, expected volumes and any specific packaging or branding requirements.
Our team will review the project requirements and contact you to discuss the appropriate manufacturing and supply model.
Contact Our OEM Team
Archem Diagnostics operates under an established quality management system for the development and manufacturing of IVD products. Our quality processes cover key stages from raw material control and production to quality control and final product release.
Relevant quality certificates and documentation are available upon request or through our Downloads section.
View Certificates
The regulatory status of Archem products may vary depending on the product and target market. Relevant CE and IVDR documentation can be provided according to the regulatory status of the requested product.
For product-specific regulatory information, please contact our team with the product name or reference number.
Contact Us
Yes. Archem Diagnostics maintains a quality management system in accordance with ISO 13485 for medical devices and in vitro diagnostic products.
The current certificate and its scope can be accessed through our certificates section.
Depending on the product and market requirements, Archem can provide relevant technical and regulatory documentation, such as Instructions for Use (IFU), Safety Data Sheets (SDS), Certificates of Analysis (CoA), declarations and other product-specific documents where applicable.
For a specific document, please provide the product name and reference or lot information when contacting our team.
Downloads
Archem supports its international partners with product registration documentation according to the product, regulatory status and requirements of the target market.
As registration requirements vary by country, the required documentation is evaluated together with the local distributor or business partner.
Contact Regulatory Support
Archem applies controlled manufacturing and quality control processes throughout production, from incoming raw materials to final product release. Product performance is evaluated according to defined specifications and applicable quality requirements.
Our quality and validation processes are designed to support consistent performance across production lots.
Learn More About Quality
Yes. Archem provides technical support for its IVD reagents, including assistance with analyzer applications, reagent implementation, performance evaluation and troubleshooting.
Our technical team works with distributors, laboratories and business partners to support the effective use of Archem products.
The Archem Validation Center is our in-house facility where reagents and applications are evaluated on a range of leading clinical chemistry analyzer platforms.
It enables our technical team to assess reagent performance, analyzer compatibility and application parameters under controlled conditions.
Explore Our Validation Center
Archem evaluates reagent performance using defined validation procedures and analyzer-specific applications. Depending on the product and platform, evaluations may include relevant analytical performance parameters and application-specific requirements.
These studies help verify the suitability of reagent applications for compatible analyzer platforms.
Learn More About Validation
If your analyzer or model is not currently listed, please contact our technical team with the analyzer manufacturer, model and required assays.
Our team can review the request and evaluate whether an existing application is available or whether further technical assessment is required.
Request Compatibility Support
Yes. Archem can provide application parameters and technical guidance for compatible analyzer platforms, depending on the reagent and analyzer model.
For application support, please provide the analyzer model and required reagent information so our technical team can identify the appropriate documentation and parameters.
Request Application Support
To help our technical team evaluate your request efficiently, please provide the product name or reference, lot number, analyzer manufacturer and model, application details, and a clear description of the issue or request, where applicable.
Additional data or documentation may be requested depending on the technical case.
To place an order or request a quotation, contact our sales team with the product name or reference, required quantity, destination country and company information.
Our team will review your request and provide information about product availability, commercial terms and the appropriate supply channel for your market.
Request a Quote
Archem works with distributors and business partners across international markets. Distribution arrangements may vary depending on the country and product portfolio.
Contact our team with your country and product requirements, and we will help you identify the appropriate sales channel for your market.
Find Your Local Contact
Companies interested in becoming an Archem distributor can contact our international sales team with information about their company, market coverage, product portfolio and local IVD experience.
Potential partnerships are evaluated according to the target market, product scope and existing distribution structure.
Become a Distributor
Product samples may be available for technical evaluation and validation, depending on the product, market and project requirements.
Please provide the product or assay of interest, analyzer manufacturer and model, company information and intended evaluation when submitting your request.
Request a Sample
Minimum order quantities may vary depending on the product, packaging configuration and type of supply, including standard, OEM, private-label and bulk orders.
Please contact our sales team with your product and quantity requirements for project-specific information.
Request Commercial Information
Lead times vary depending on the product, order quantity, packaging requirements and type of project. OEM, private-label and customized orders may require different production timelines than standard products.
Our sales team will provide an estimated lead time after reviewing your order requirements.
Request Order Information
Our technical team answers questions specific to your instrument and application.