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            Suppliers of in vitro diagnostic products

            • Home
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            • Suppliers of in vitro diagnostic products
            in vitro diagnostic en 2

            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.

            lote a lote logo
            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

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            Quality and reliability of reports

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            Selects the best devices

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            Agility through the simplification of work routines

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            Cost reduction, savings on reagents, time, and effort

            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

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            Meets the needs of your audience

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            Helps customers reduce costs and simplify reagent change monitoring

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            Ensures product confidence

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            Demonstrates quality across batches

            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.

            Check out the updated list of manufacturers who have already secured certification for some of their POCT batches

            abbott logo

            Certified batches

            ProdutoLote do DispositivoValidade do Lote
            BinaxNOW™ RSV82380610/11/2025
            BinaxNOW™ RSV83849111/12/2025
            BinaxNOW™ RSV85731311/12/2025
            Panbio COVID-19 Ag Rapid Test41ADH673A22/11/2025
            Panbio COVID-19/Flu A&B Rapid Panel62ADJ005A21/01/2026
            ABON Strep A Rapid Test Strip000085246511/03/2026
            Determine HIV-1/2000081842001/05/2025
            Bioline HIV/Syphilis Duo06ADI073B24/09/2025
            Bioline HIV/Syphilis Duo06ADI085A07/11/2025
            Bioline HIV/Syphilis Duo06ADJ011A12/02/2026
            ABON Syphilis Ultra Rapid Test Strip000076175005/06/2025
            ABON Syphilis Ultra Rapid Test Strip000085328625/02/2026
            ABON Syphilis Ultra Rapid Test Strip000085328725/02/2026
            ABON Strep A Rapid Test Strip000085246210/03/2026
            Panbio COVID-19/Flu A&B Rapid Panel62ADJ008A14/03/2026
            Panbio COVID-19/Flu A&B Rapid Panel62ADJ008B21/01/2026
            Panbio COVID-19/Flu A&B Rapid Panel62ADJ008C19/03/2026
            Bioline Influenza Ag A/B/A (H1N1)19BFJ001A26/03/2026
            Bioline Influenza Ag A/B/A (H1N1)19BFJ003A17/04/2026
            Panbio COVID-19/Flu A&B Rapid Panel62ADJ005B21/01/2026
            Panbio COVID-19/ Flu A&B Panel (Nasal)62BDJ008A17/07/2026
            Panbio COVID-19/ Flu A&B Panel (Nasal)62BDJ009A17/07/2026
            Bioline Dengue Duo11DDJ101A04/12/2026
            Bioline Dengue Duo11DDJ102A04/12/2026
            ABON Strep A Rapid Test Strip000093384624/10/2026
            ABON Strep A Rapid Test Strip000096816112/02/2027
            BIOLINE HIV/Syphilis Duo06ADJ033A09/05/2026
            Bioline Influenza Ag A/B/A (H1N1)19BFJ008D08/11/2026
            Determine HIV-1/2000090446910/01/2026
            BinaxNOW™ RSV88820504/06/2026

             

            lg bio

            Certified batches

            ProdutoLote do DispositivoValidade do Lote
            AFIAS PSA NeoPSTXA06X14/05/2025
            AFIAS Vitamin D NeoVETYA68X03/06/2025
            LipidPro GlicoseN23L123B111/12/2025
            MicrocuvettesHBPTH1709/08/2025
            AFIAS TSHTSUBA26X04/10/2025
            AFIAS Vitamin D Neo VEUBA88X05/10/2025
            MicrocuvettesHBPTK0512/11/2025
            MicrocuvettesHBPUB3526/02/2026
            AFIAS HbA1c NeoAAUCA96X04/11/2025
            AFIAS β-HCG PlusHCTKA21G28/07/2025
            AFIAS β-HCG PlusHCUCA25G13/11/2025
            AFIAS PSA NeoPSUBA10X22/10/2025
            AFIAS AMHMHUBA19G25/10/2025
            AFIAS Vitamin D NeoVEUHB26X25/04/2026
            AFIAS TSHTSUHA45X25/04/2026
            AFIAS PSA NeoPSUHA12X21/04/2026
            LipidPro GlicoseN24J023E101/10/2026
            AFIAS β-HCG PlusHCUHA29G29/04/2026
            Element Multi Perfil LipídicoNPJ18ZK1918/11/2025
            AFIAS TSHTSUKA61X19/07/2026
            AFIAS PSA NeoPSUKA14X18/07/2026
            AFIAS AMHMHUHA20G12/04/2026
            AFIAS β-HCG PlusHCUKA31G28/07/2026

            eco diagnostica

            Certified batches

            ProdutoLote do DispositivoValidade do Lote
            FLU/RSV/SARS-CoV-2 Ag ECO Teste20240701312/05/2026
            FLU/RSV/SARS-CoV-2 Ag ECO Teste20240802027/06/2026
            COVID-19 Ag ECO Teste20241000726/03/2026
            Covid / FLU A/B Ag Combo ECO Teste20240901209/11/2026
            ECO F HCG62155G2AC15/11/2025
            ECO F HCG62155G3AC15/11/2025
            ECO F HbA1c60757F1AC14/01/2026
            HIV/Sifilis ECO Teste20241000829/10/2026
            PL Strip ECO Teste20253B1L2BA0410/09/2025
            Dengue DUO ECO Teste20240805224/03/2026
            Dengue DUO ECO Teste20241100724/03/2026
            Dengue Duo Combo ECO Teste20241201503/10/2026
            Dengue Ag Combo ECO Teste20241202203/10/2026
            FLU/RSV/SARS-CoV-2 Ag ECO Teste20241200910/07/2026
            Glicose STRIP ECO Teste22459D1AC112/09/2026
            Glicose STRIP ECO Teste22459P1AC122/09/2026
            HIV/Sifilis ECO Teste20250102929/10/2026
            Glicose STRIP ECO Teste2245BD1AC112/11/2026
            ECO F HCG6215965AC05/03/2026
            ECO F HCG6215964AC05/03/2026
            ECO F HbA1c60756M1AC20/12/2025
            Glicose STRIP ECO Teste2245CS1AC125/12/2026
            Covid / FLU A/B Ag Combo ECO Teste20250105304/12/2026
            HIV/Sifilis ECO Teste20250400629/10/2026

            medlevensohn

            Certified batches

            ProdutoLote do DispositivoValidade do Lote
            MedTeste Dengue NS1DEG2311001328/11/2025
            MedTeste COVID-19 + Influenza A&B Ag Combo (Teste Rápido)CFG2403000511/03/2026
            MedTeste Dengue NS1DEG2403000612/03/2026
            MedTeste Dengue NS1DEG2405001728/05/2026
            MedTeste Dengue NS1DEG2405001828/05/2026

            logo micobiomed 1

            Certified batches

            ProdutoLote do DispositivoValidade do Lote
            Tira de teste de Hemoglobina VERI-Q MHS-2MRM24GN1EA31/01/2026
            Tira de teste de Hemoglobina VERI-Q MHS-2MRM24GN1EB31/01/2026
            Tira de teste de Lipídio VERI-Q MLS-2MLN24HY10A11/02/2026
            Tira de teste de Lipídio VERI-Q MLS-2MLN24HY1TA28/02/2026

            wama diagnostica logo 1

            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
            Imuno-Rápido Tipagem Sanguínea ABO&RH24L06131/12/2026
            Bio Quick HbA1c24C03430/06/2026
            Bio Quick Perfil Lipídico24F06231/08/2026
            Imuno-Rápido Tipagem Sanguínea ABO&RH24J24330/11/2026
            Imuno-Rápido Tipagem Sanguínea ABO&RH25B13430/06/2026

            ×
            especialista em lote alote
            lote a lote logo
            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.

            Collaborative Supplier

            Strategic partnership to enhance diagnostic quality.

            Become a Collaborative Supplier Partner of Controllab and strengthen the credibility of your analytical systems by adding value to your reagents, devices, equipment, and in vitro diagnostic services.

            Discover the benefits of this partnership

            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.

            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.

            Calibração de Instrumentos (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.

            October 23, 2023
            WP 1024 535 37
            October 23, 2023
            Categories
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            LabPoc garante valores de referência para dispositivos ao selar parceria com a Controllab

            Iniciativa entre as empresas proporciona mais segurança às rotinas analíticas e evidencia compromisso com a qualidade dos equipamentos. O LabPoc agora faz parte do programa Fornecedor […]
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            March 6, 2023
            WP 1024 535 23
            March 6, 2023
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            • Fornecedores de Produtos
            • Highlights
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            FirstLab sela parceria com a Controllab e garante valores de referência para tiras de urina

            Iniciativa entre as empresas proporciona mais segurança para as rotinas analíticas. O programa Fornecedor Colaborador da Controllab conta com a adesão da FirstLab. É uma parceria […]
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            February 21, 2022
            Erba
            February 21, 2022
            Categories
            • Quality Control
            • Supplier of Products

            Erba Mannheim integrates Controllab’s supplier program

            Company that works with hematological systems closes a partnership to ensure the reference values ​​of Erba H560 and Elite 580 equipment Erba Mannheim is another partner […]
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                      PRM 0009

                      Accreditation Cgcre/Inmetro - Certified Reference Material Producer

                      Controllab has been accredited as a Certified Reference Material Producer (MRC) since 2016 by Inmetro’s General Coordination for Accreditation (CGCRE), under the PMR 0009 number. The assessment of this conformity is carried out according to the requirements established in ABNT NBR standards ISO 17034 and Inmetro, thus ensuring competence for the production of MRCs, according to the Scope of Accreditation.
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                      Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

                      CAL 0214

                      Accreditation Cgcre/Inmetro - Calibration Laboratory

                      In December 2002, the Calibration Laboratory was accredited by Inmetro’s General Coordination for Accreditation (CGCRE). With this recognition, it became an integral part of the Brazilian network of accredited laboratories, under nº214. Since then, it is periodically evaluated for the maintenance and/or extension of accreditation.

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                      Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
                      Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).