Batch-to-Batch
Certification Program
For manufacturers and distributors
The program evaluates each new batch before it is used in routine operations. The certificate is provided free of charge by the manufacturer to the services performing the tests.
This commitment to quality ensures that the distributed batches have validated performance among them, preventing unwanted variations.
The Batch-to-Batch Certification Program has the institutional support of SBPC/ML and CBDL, reinforcing the initiative’s relevance and the sector’s commitment to reliability and safety in in vitro diagnostic testing.
How does Batch-to-Batch Certification work?
Priority for single-use POCT.
1
COMPARES
the new batch with the previous one.
2
EVALUATES
performance based on
statistical and clinical criteria.
3
CERTIFIES
equivalence to ensure
continuity and confidence.
Benefits for organizations
performing tests
Include batch certification in your routine and achieve:
- Safety when changing batches
- Fewer internal checks
- Reduced costs and quality checks
- More consistent and reliable results
- Compliance with standards and regulations
Healthcare services, how to obtain the certificate?
Simply request it from the manufacturer — the certificate is free for you.
Benefits for manufacturers and registration holders
Certify your product batch and strengthen your brand’s reputation:
- Technical validation of batch performance
- Transparency with customers
- Competitive advantage
- Reduction of post-sale issues
- Meets the needs of testing laboratories, reducing their costs and efforts when changing batches
Manufacturer, how to obtain the certificate?
Contact Controllab.
Check the updated list of certified POCT batches
Manufacturers participating in the program meet the needs of their customers and ensure trust in the devices they market.
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Abbott Clearview Strep A | 0001145590 | 08/07/2027 |
| Abbott Clearview Strep A | 0001165412 | 27/08/2027 |
| ABON Strep A Rapid Test Strip | 0000933846 | 24/10/2026 |
| ABON Strep A Rapid Test Strip | 0000968161 | 12/02/2027 |
| BinaxNOW™ RSV | 888205 | 04/06/2026 |
| Bioline Dengue Duo | 11DDJ101A | 04/12/2026 |
| Bioline Dengue Duo | 11DDJ102A | 04/12/2026 |
| Bioline Dengue Duo | 11DDJ103A | 04/12/2026 |
| BIOLINE HIV/Syphilis Duo | 06ADJ033A | 09/05/2026 |
| Bioline Influenza Ag A/B/A (H1N1) | 19BFJ003A | 17/04/2026 |
| Bioline Influenza Ag A/B/A (H1N1) | 19BFJ008D | 08/11/2026 |
| Bioline Influenza Ag A/B/A (H1N1) | 19BFJ009A | 12/12/2026 |
| Bioline Influenza Ag A/B/A (H1N1) | 19BFK002B | 22/06/2027 |
| Bioline Zika IgM | 12BDJ004F | 19/08/2026 |
| Bioline Zika IgM | 12BDK001B | 08/07/2026 |
| Bioline Zika IgM | 12BDK001C | 12/10/2026 |
| Bioline Zika IgM | 12BDK002A | 03/01/2027 |
| Determine™ HIV Early Detect | 0001008046 | 25/08/2026 |
| Determine™ HIV Early Detect | 0000980764 | 11/08/2026 |
| Panbio COVID-19/ Flu A&B Panel (Nasal) | 62BDJ008A | 17/07/2026 |
| Panbio COVID-19/ Flu A&B Panel (Nasal) | 62BDJ009A | 17/07/2026 |
| Panbio COVID-19/ Flu A&B Panel (Nasal) | 62BDJ012B | 09/12/2026 |
| Panbio COVID-19/Flu A&B Rapid Panel | 62ADJ009D | 21/07/2026 |
| Panbio COVID-19/Flu A&B Rapid Panel | 62ADJ010A | 01/08/2026 |
| Panbio COVID-19/Flu A&B Rapid Panel | 62ADJ009A | 16/04/2026 |
| Prostate Specific Antigen Semi-Quantitative | 0000913433 | 07/08/2026 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| AFIAS AMH | MHUHA20G | 12/04/2026 |
| AFIAS PSA Neo | PSUHA12X | 21/04/2026 |
| AFIAS PSA Neo | PSUKA14X | 18/07/2026 |
| AFIAS TSH | TSUHA45X | 25/04/2026 |
| AFIAS TSH | TSUKA61X | 19/07/2026 |
| AFIAS Vitamin D Neo | VEUHB26X | 25/04/2026 |
| AFIAS β-HCG Plus | HCUHA29G | 29/04/2026 |
| AFIAS β-HCG Plus | HCUKA31G | 28/07/2026 |
| LipidPro Glicose | N24J023E1 | 01/10/2026 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Covid / FLU A/B Ag Combo ECO Teste | 202409012 | 09/11/2026 |
| Covid / FLU A/B Ag Combo ECO Teste | 202501053 | 04/12/2026 |
| Covid / FLU A/B Ag Combo ECO Teste | 202508012 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste | 202509001 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603009 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603011 | 31/12/2027 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603015 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603017 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603019 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603008 | 03/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste | 202603016 | 13/05/2028 |
| COVID-19 Ag Combo ECO Teste | 202511015 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste | 202511016 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste | 202511017 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste | 202511018 | 25/09/2026 |
| Dengue Ag Combo ECO Teste | 202412022 | 03/10/2026 |
| Dengue Duo Combo ECO Teste | 202412015 | 03/10/2026 |
| ECO F HbA1c | 6076133AC | 02/07/2026 |
| ECO F HbA1c | 6076135AC | 02/07/2026 |
| ECO F HbA1c | 60765X1D1 | 30/11/2026 |
| ECO F HbA1c | 6076651D1 | 04/12/2026 |
| ECO F HbA1c | 60765M3D1 | 20/11/2026 |
| ECO F HCG | 62163M1D1 | 05/08/2026 |
| ECO F HCG | 62168B2D1 | 10/02/2027 |
| ECO F HCG | 62168B3D1 | 10/02/2027 |
| ECO F HCG | 6216911D1 | 28/02/2027 |
| ECO F HCG | 6216991D1 | 08/03/2027 |
| ECO F TSH | 61963R1D1 | 24/09/2026 |
| ECO F TSH | 61963R2D1 | 24/09/2026 |
| ECO F TSH | 61965H1D1 | 16/11/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202407013 | 12/05/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202408020 | 27/06/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202412009 | 10/07/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202503020 | 22/07/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202505015 | 22/07/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202505016 | 03/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202505025 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202505026 | 03/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202505027 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202508022 | 30/06/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202508011 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202511020 | 30/06/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202511022 | 17/08/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202511023 | 17/08/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202602012 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202602020 | 15/09/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste | 202602014 | 17/08/2027 |
| Glicose STRIP ECO Teste | 22459D1AC1 | 12/09/2026 |
| Glicose STRIP ECO Teste | 22459P1AC1 | 22/09/2026 |
| Glicose STRIP ECO Teste | 2245BD1AC1 | 12/11/2026 |
| Glicose STRIP ECO Teste | 2245CS1AC1 | 25/12/2026 |
| Glicose STRIP ECO Teste | 22463U1AC1 | 27/03/2027 |
| Glicose STRIP ECO Teste | 22465P1AC1 | 22/5/2027 |
| H. pylori Ab ECO Teste | 202506004 | 22/12/2026 |
| HIV/Sifilis ECO Teste | 202410008 | 29/10/2026 |
| HIV/Sifilis ECO Teste | 202501029 | 29/10/2026 |
| HIV/Sifilis ECO Teste | 202504006 | 29/10/2026 |
| HIV/Sifilis ECO Teste | 202508017 | 29/10/2026 |
| PL Strip ECO Teste | 20263Q1L2BA04 | 23/09/2026 |
| PL Strip ECO Teste | 20265W1L2BA04 | 29/11/2026 |
| PL Strip ECO Teste | 2026B21L2BA04 | 01/05/2027 |
| PL Strip ECO Teste | 2026CN1L2BA04 | 21/06/2027 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| MedTeste Dengue Ab e Ag Combo | DGC24090002 | 01/09/2026 |
| MedTeste Dengue NS1 | DEG24050017 | 28/05/2026 |
| MedTeste Dengue NS1 | DEG24050018 | 28/05/2026 |
| MedTeste Dengue NS1 | DEG24110004 | 21/11/2026 |
| MedTeste Dengue NS1 | DEG24080011 | 25/08/2026 |
| MedTeste Dengue NS1 | DEG25060002 | 03/06/2027 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Tira de teste de Lipídio VERI-Q MLS-2 | MLN24HY10A | 11/02/2026 |
| Tira de teste de Lipídio VERI-Q MLS-2 | MLN24HY1TA | 28/02/2026 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Ácido Úrico Acuteck Strip | EU2503007 | 28/02/2027 |
| Covid-19 Ag Flu A & B Combo Assure Test – Assure Tech | I2505022 | 30/04/2027 |
| Glicemia Acuteck | ED2504007 | 31/03/2027 |
| H. pylori AC Assure Test | I2504181 | 31/03/2027 |
| HBsAg Assure Test | I2504177 | 31/03/2027 |
| HCV Assure Test | I2504175 | 31/03/2027 |
| Sífilis Assure Test | I2504179 | 31/03/2027 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Prati Donaduzzi Diagnósticos Teste Rápido de Gravidez em Tira | HCG25100020 | 30/09/2028 |
| Prati Donaduzzi Diagnósticos Teste Rápido de Gravidez hCG em Bastão | HCG25100021 | 30/09/2028 |
| Prati Donaduzzi Diagnósticos Teste Rápido de Gravidez hCG Digital | HCG25100022 | 30/09/2027 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Bio Quick HbA1c | 24C034 | 30/06/2026 |
| Bio Quick Perfil Lipídico | 24F062 | 31/08/2026 |
| FATControl PRO | 25A185 | 31/05/2026 |
| Imuno-Rápido COVID-19 e Influenza Ag | 25L001X | 30/06/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag | 25K117X | 30/06/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag | 26A099X | 30/11/2027 |
| Imuno-Rápido DENGUE DUO | 26A083 | 30/11/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 | 25E171B | 31/12/2026 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 | 26A128X | 30/11/2027 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 24L061 | 31/12/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 24J243 | 30/11/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 25B134 | 30/06/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 25D054 | 30/06/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 25J086 | 31/10/2027 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 25L045 | 31/12/2027 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 26A036 | 31/01/2028 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 | 26A107XB | 30/11/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 | 26B062 | 30/09/2027 |
(21) 98258-0033 More solutions serving organizations performing tests and suppliers of in vitro diagnostic products.
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Confirms that your analytical system delivers linear and reliable results across the entire measurement range.
For manufacturers and distributors
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Develops customized internal controls to ensure accuracy, reliability, and support for market entry.
Collaborating Supplier
For manufacturers and distributors
Ensures reference values for your analytical system in Controllab’s Internal Controls.
Performance Dashboard
Tests methods and equipment, ensuring reliability and quality in testing.
Linearity Check
Ensures reference values for your analytical system in Controllab’s Internal Controls.
Customized Internal Quality Control for Analytical Systems
For manufacturers and distributors
Develops customized internal controls to ensure accuracy, reliability, and support for market entry.
GET TO KNOW CONTROLLAB
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