In Vitro Diagnostic

Partnerships between Controllab and suppliers of in vitro diagnostic products offer quality assurance, more interaction and knowledge exchange.

Controllab, in its continuous search to disseminate the quality of the results of the exams, provides diagnostic suppliers with solutions that promote the quality of their products. Among them, participation in programs that provide continuous improvement of laboratory results and in vitro diagnostic products.

Suppliers: discover the solutions that meet the needs of your audience and strengthen the trust in the devices you market.

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Do you know about quality certification for POCTs?

POCTs with certified batches are a strategic choice that promotes reliability and safety in the analytical processes of tests.

Discover the benefits that certified batches promote

Clinical Analysis Establishments

The certificate from the Programa Lote a Lote, issued by Controllab, ensures consistency in the POCT batches in use compared to previous batches from the same manufacturer. This certification brings efficiency and savings to laboratories and other services that perform clinical analysis tests.

Manufacturers

Manufacturers and registration holders participating in the program meet the needs of their audience by helping reduce costs and efforts in monitoring the customer’s new reagent batch changes. In doing so, they ensure confidence in the devices they offer.

In this program, the batches of these products are evaluated according to relevant guidelines and literature, using materials representative of routine use. The goal is to verify if the results between batches are consistent and maintain analytical performance.

This service does not replace the validation process or other checks conducted by manufacturers or device holders, nor should it be used for registration purposes.

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Certified batches

ProdutoLote do DispositivoValidade do Lote
Imuno-Rápido Tipagem Sanguínea ABO&RH24I19030/11/2025
Imuno-Rápido Tipagem Sanguínea ABO&RH24I190B31/03/2026
Imuno-Rápido HIV Triline24E02031/01/2026

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For more information, access the exclusive channel of the Certificação Lote a Lote and speak with the specialist for this solution. Whatsapp controllab 1 (21) 98258-0033

More solutions designed for clinical laboratories and suppliers of in vitro diagnostic products.

Linearity Check and Calibration

In this program, test items produced with a rigorous serial dilution are sent, in order to cover a larger range of concentrations. After analyzing and sending the results, Controllab performs the verification (by interlaboratory comparison or internally) of the analytical system’s ability to reproduce results linearly according to its specification.

Performance Panel

Used to evaluate and validate new test methods and equipment, the service demonstrates the reliability of the systems. Composed of positive and negative items, with varied concentrations and heterologous items obtained from different donors in the regions of Brazil, this panel is previously valued by different analysis methodologies. The use of low reactive control materials allows obtaining valuable information regarding analytical capacity and variations between reagent lots.

Partnership Supplier Collaborator

As a Supplier Collaborator, the contracting company provides its products* so that Controllab can carry out repeated analysis sequences for internal control valuation. In other words, the reference values for the supplier's material become part of the instruction sheet of Controllab's internal control programs, without depending on a minimum number of results from the supplier's system.

Controllab also verifies the proficiency testing materials with the analytical system of the Supplier Collaborator. This partnership is continuous, and for each new control material produced, whether for use in external or internal control, analyses and valuations will be carried out in the supplier's system. This collaboration fosters even greater integration between the supplier, the clinical analysis service, and Controllab, as the program's dynamic encourages information exchange and better support for clients in resolving doubts and questions related to control materials and their behavior.

Since the Supplier Collaborator is also a user of the internal and external control programs, having this support is further evidence of the company's commitment to the quality of the products offered. Consequently, there is greater reliability for laboratories seeking quality verification when choosing a kit, for example.

*The provision of products must include reagents, equipment, consumables, installation, training, preventive and corrective technical assistance, and any other resources necessary for testing.

Development of customized internal control for analytical systems

Internal control is a tool that enables greater reliability and accuracy of results. The absence of reference values for an analytical system may represent an obstacle for suppliers to enter the market. Controllab has extensive technology and productive capacity in the development of customized controls for the various analytical systems available on the market. In this way, the manufacturer has the opportunity to have a specific quality control material to offer along with his system.

Além das soluções descritas, os In addition to the solutions described, suppliers can benefit from services that add more reliability and precision to their processes. See the options available for Certified Reference Materials and Instrument Calibration.

Materiais de Referência Certificados (MRC)

It adds more precision and traceability to the analytical process.

Calibration of Instruments (CA)

Prevents measurement errors in analysis.

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HAVE AN ENVIRONMENT WITH ANALYSIS OF EXCELLENCE

Controllab offers complete solutions for quality and assertiveness of results. These solutions facilitate recognition for accreditation processes and regulatory bodies.
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Partners of the Supplier Collaborator Program

Many companies join the Supplier Collaborator partnership to demonstrate and ensure the quality of their products. Check the related news to see the benefits these companies have gained.

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