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 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 Tira Teste 0001145590 | Tampão 1 0001137100 | Tampão 2 0001137102 | 0001145590 | 08/07/2027 |
| Abbott Clearview Strep A Tira Teste 0001165412 | Tampão 1 0001157806 | Tampão 2 0001157822 | 0001165412 | 27/08/2027 |
| Abbott Clearview Strep A Tira Teste 0001190514 | Tampão 1 0001171081 | 0001190514 | 03/11/2027 |
| Abbott Clearview Strep A Tira Teste 0001196583 | Tampão 1 0001171081 | Tampão 2 0001171082 | 0001196583 | 01/12/2027 |
| ABON Strep A Rapid Test Strip Tira Teste 0000933846 | Tampão 1 0000916447 | Tampão 2 0000927421 | 0000933846 | 24/10/2026 |
| ABON Strep A Rapid Test Strip Tira Teste 0000968161 | Tampão 1 0000948944 | Tampão 2 0000947035 | 0000968161 | 12/02/2027 |
| Bioline Dengue Duo | 11DDJ101A | 04/12/2026 |
| Bioline Dengue Duo | 11DDJ102A | 04/12/2026 |
| Bioline Dengue Duo Abbott Clearview Strep A Tira Teste 11DDJ103A | Tampão 1 11CDDK001 | 11DDJ103A | 04/12/2026 |
| BIOLINE HIV/Syphilis Duo Tira Teste 06ADK038B | Tampão 1 06ADDK044 | 06ADK038B | 30/11/2027 |
| Bioline Influenza Ag A/B/A (H1N1) Tira Teste 19BFJ008D | Tampão 1 19AFDJ022 | 19BFJ008D | 08/11/2026 |
| Bioline Influenza Ag A/B/A (H1N1) Tira Teste 19BFJ009A | Tampão 1 19AFDJ035 | 19BFJ009A | 12/12/2026 |
| Bioline Influenza Ag A/B/A (H1N1) Tira Teste 19BFK002B | Tampão 1 19AFDJ031 | 19BFK002B | 22/06/2027 |
| Bioline Influenza Ag A/B/A (H1N1) Tira Teste 19BFK004B | Tampão 1 19AFDK002 | 19BFK004B | 04/11/2027 |
| Bioline Zika IgM Tira Teste 12BDJ004F | Tampão 1 12BDDK002 | 12BDJ004F | 19/08/2026 |
| Bioline Zika IgM Tira Teste 12BDK001B | Tampão 1 12BDDK001 | 12BDK001B | 08/07/2026 |
| Bioline Zika IgM Tira Teste 12BDK001C | Tampão 1 12BDDK003 | 12BDK001C | 12/10/2026 |
| Bioline Zika IgM Tira Teste 12BDK002A | Tampão 1 12BDDK004 | 12BDK002A | 03/01/2027 |
| Bioline Zika IgM Tira Teste 12BDK002B | Tampão 1 12BDDK005 | 12BDK002B | 23/03/2027 |
| Bioline Zika IgM Tira Teste 12BDK003A | Tampão 1 12BDDK005 | 12BDK003A | 23/03/2027 |
| Bioline Zika IgM Tira Teste 12BDK003B | Tampão 1 12BDDK006 | 12BDK003B | 19/05/2027 |
| Bioline Zika IgM Tira Teste 12BDK004A | Tampão 1 12BDDK006 | 12BDK004A | 19/05/2027 |
| Determine™ HIV Early Detect Tira Teste 0000980759 | 0000980764 | 11/08/2026 |
| Determine™ HIV Early Detect Tira Teste 0000983279 | 0001008046 | 25/08/2026 |
| 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) Tira Teste 62BDJ12B | Tampão 1 62ADDJ020 | 62BDJ012B | 09/12/2026 |
| Panbio COVID-19/Flu A&B Rapid Panel Tira Teste 62ADJ009D | Tampão 1 62ADDJ011 | 62ADJ009D | 21/07/2026 |
| Panbio COVID-19/Flu A&B Rapid Panel Tira Teste 62ADJ010A | Tampão 1 62ADDJ013 | 62ADJ010A | 01/08/2026 |
| Prostate Specific Antigen Semi-Quantitative Tira Teste 0000913433 | Tampão 1 0000911622 | 0000913433 | 07/08/2026 |
| 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 Tira Teste 202501053 | Tampão 1 SFB055045-24 | 202501053 | 04/12/2026 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202508012 | Tampão 1 54E65L1Z8 | 202508012 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202509001 | Tampão 1 54E65W1Z8 | 202509001 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603009 | Tampão 1 54E6BE1S6 | 202603009 | 04/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603011 | Tampão 1 54E6BE1S6 | 202603011 | 31/12/2027 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603015 | Tampão 1 54E6BE1S6 | 202603015 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603017 | Tampão 1 54E6BE1S6 | 202603017 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603019 | Tampão 1 54E6BE1S6 | 202603019 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603008 | Tampão 1 54E6BE1S6 | 202603008 | 03/06/2027 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603016 | Tampão 1 54E6BE1S6 | 202603016 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202603033 | Tampão 1 54E6BE1S6 | 202603033 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202604017 | Tampão 1 54E6BE1S6 | 202604017 | 13/05/2028 |
| Covid / FLU A/B Ag Combo ECO Teste Tira Teste 202604018 | Tampão 1 54E6CH2S6 | 202604018 | 18/05/2028 |
| COVID-19 Ag Combo ECO Teste Tira Teste 202511015 | Tampão 1 52H63E1S8 | 202511015 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste Tira Teste 202511016 | Tampão 1 52H63E1S6 | 202511016 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste Tira Teste 202511017 | Tampão 1 52H63E1S6 | 202511017 | 25/09/2026 |
| COVID-19 Ag Combo ECO Teste Tira Teste 202511018 | Tampão 1 52H63E1S6 | 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 Tira Teste 6076133AC | Tampão 1 6075AH1S4 | 6076133AC | 02/07/2026 |
| ECO F HbA1c Tira Teste 6076135AC | Tampão 1 6075AH1S4 | 6076135AC | 02/07/2026 |
| ECO F HbA1c Tira Teste 60765X1D1 | Tampão 1 6076421D1 | 60765X1D1 | 30/11/2026 |
| ECO F HbA1c Tira Teste 6076651D1 | Tampão 1 6074BV1S4/1 | 6076651D1 | 04/12/2026 |
| ECO F HbA1c Tira Teste 60765M3D1 | Tampão 1 60765V1D2 | 60765M3D1 | 20/11/2026 |
| ECO F HCG Tira Teste 62163M1D1 | Tampão 1 62155N1S4 | 62163M1D1 | 05/08/2026 |
| ECO F HCG Tira Teste 62168B2D1 | Tampão 1 6216812D1 | 62168B2D1 | 10/02/2027 |
| ECO F HCG Tira Teste 62168B3D1 | Tampão 1 6216812D1 | 62168B3D1 | 10/02/2027 |
| ECO F HCG Tira Teste 6216911D1 | Tampão 1 6216812D1 | 6216911D1 | 28/02/2027 |
| ECO F HCG Tira Teste 6216991D1 | Tampão 1 6216814D1 | 6216991D1 | 08/03/2027 |
| ECO F TSH Tira Teste 61963R1D1 | Tampão 1 61959L1S4 | 61963R1D1 | 24/09/2026 |
| ECO F TSH Tira Teste 61963R2D1 | Tampão 1 61959L1S4 | 61963R2D1 | 24/09/2026 |
| ECO F TSH Tira Teste 61965H1D1 | Tampão 1 6195B81S4 | 61965H1D1 | 16/11/2026 |
| 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 Tira Teste 202503020 | Tampão 1 56L5BM1S6 | 202503020 | 22/07/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202505015 | Tampão 1 56L5BM1S6 | 202505015 | 22/07/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202505016 | Tampão 1 56L5BM1S6 | 202505016 | 03/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202505025 | Tampão 1 56L56U1S6 | 202505025 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202505026 | Tampão 1 56L5641S6 | 202505026 | 03/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202505027 | Tampão 1 56L5BM1S6 | 202505027 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202508022 | Tampão 1 56L66G1S6 | 202508022 | 30/06/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202508011 | Tampão 1 56L66G1S6 | 202508011 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202511020 | Tampão 1 56L67F1S6 | 202511020 | 30/06/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202511022 | Tampão 1 56L67U1S6 | 202511022 | 17/08/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202511023 | Tampão 1 56L67F1S6 | 202511023 | 17/08/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202602012 | Tampão 1 56L66G1S6 | 202602012 | 09/12/2026 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202602020 | Tampão 1 56L6B61S6 | 202602020 | 15/09/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202602014 | Tampão 1 56L6B61S6 | 202602014 | 17/08/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202604011 | Tampão 1 56L66G1S6 | 202604011 | 15/09/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202604012 | Tampão 1 56L6CH2S6 | 202604012 | 17/11/2027 |
| FLU/RSV/SARS-CoV-2 Ag ECO Teste Tira Teste 202604013 | Tampão 1 56L6CH2S6 | 202604013 | 30/11/2027 |
| 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 | 22/05/2027 |
| H. pylori Ab ECO Teste Tira Teste 202506004 | Tampão 1 202506004 | 202506004 | 22/12/2026 |
| HIV/Sifilis ECO Teste | 202410008 | 29/10/2026 |
| HIV/Sifilis ECO Teste | 202501029 | 29/10/2026 |
| HIV/Sifilis ECO Teste Tira Teste 202504006 | Tampão 1 202504008 | 202504006 | 29/10/2026 |
| HIV/Sifilis ECO Teste Tira Teste 202508017 | Tampão 1 202508017 | 202508017 | 29/10/2026 |
| PL Strip ECO Teste Tira Teste 2026B21L2BA04 | 20263Q1L2BA04 | 23/09/2026 |
| PL Strip ECO Teste | 20265W1L2BA04 | 29/11/2026 |
| PL Strip ECO Teste Tira Teste 2026B21L2BA04 | 2026B21L2BA04 | 01/05/2027 |
| PL Strip ECO Teste Tira Teste 2026CN1L2BA04 | 2026CN1L2BA04 | 21/06/2027 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| Família GPP-100 HbA1c | 1072251119 | 18/11/2026 |
| Produto | Lote do Dispositivo | Validade do Lote |
|---|---|---|
| MedTeste Dengue Ab e Ag Combo Tira Teste DGC24090002 | Tampão 1 24080148 | DGC24090002 | 01/09/2026 |
| MedTeste Dengue NS1 Tira Teste DEG24110004 | Tampão 1 24110004 | DEG24110004 | 21/11/2026 |
| MedTeste Dengue NS1 Tira Teste DEG24080011 | Tampão 1 24070003 | DEG24080011 | 25/08/2026 |
| MedTeste Dengue NS1 Tira Teste DEG25060002 | Tampão 1 25060169-T | 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 Tira I2505022 | Tampão 1 I2505022F | I2505022 | 30/04/2027 |
| Glicemia Acuteck | ED2504007 | 31/03/2027 |
| H. pylori AC Assure Test | I2504181 | 31/03/2027 |
| HBsAg Assure Test Tira I250418 | Tampão 1 I2504181F | I2504177 | 31/03/2027 |
| HCV Assure Test Tira I2504175 | Tampão 1 I2504175F | I2504175 | 31/03/2027 |
| Sífilis Assure Test Tira I2504179 | Tampão 1 I2504179F | 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 Tira Teste 24C034 | Tampão 1 24C036 | 24C034 | 30/06/2026 |
| Bio Quick HbA1c Tira Teste 26B128 | Tampão 1 26B127 | 26B130 | 31/03/2028 |
| Bio Quick HCG Tira Teste 26B133 | Tampão 1 26B132 | 26B135 | 31/03/2028 |
| Bio Quick Perfil Lipídico | 24F062 | 31/08/2026 |
| Hemocheck | 25K027 | 31/03/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag Tira Teste 25K117X | Tampão 1 25K121 | 25K117X | 30/06/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag Tira Teste 25L001X | Tampão 1 25L005 | 25L001X | 30/06/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag Tira Teste 26A099X | Tampão 1 26A103 | 26A099X | 30/11/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag Tira Teste 26D146 | Tampão 1 26D145 | 26D129 | 31/12/2027 |
| Imuno-Rápido COVID-19 e Influenza Ag Tira Teste 26E046X | Tampão 1 26E050 | 26E046X | 31/03/2028 |
| Imuno-Rápido DENGUE DUO Tira Teste 26A075 | Tampão 1 26A071 | Tampão 2 26A072 | 26A083 | 30/11/2027 |
| Imuno-Rápido DENGUE DUO Tira Teste 26B173 | Tampão 1 26A072 | Tampão 2 26D092 | 26B181B | 30/09/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 25E168 | Tampão 1 25E174 | 25E171B | 31/12/2026 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 26A073X | Tampão 1 26A131 | 26A128X | 30/11/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 26A104X | Tampão 1 26A110 | 26A107XB | 30/11/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 26B059 | Tampão 1 26B065 | 26B062 | 30/09/2027 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 26D019X | Tampão 1 26C124 | 26D022XB | 29/02/2028 |
| IMUNO-RÁPIDO DENGUE NS1 Ag 30 Tira Teste 26D019X | Tampão 1 26D025 | 26D022X | 29/02/2028 |
| Imuno-Rápido RespiCombo Tira Teste 26A172 | Tampão 1 26A173 | 26A174 | 31/03/2028 |
| Imuno-Rápido RespiCombo Tira Teste 26C083 | Tampão 1 26C082 | 26C083B | 31/03/2028 |
| Imuno-Rápido RespiCombo Tira Teste 26D146 | Tampão 1 26D145 | 26D146 | 31/05/2028 |
| Imuno-Rápido RespiCombo Tira Teste 26E184 | Tampão 1 26E183 | 26E184 | 30/06/2028 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH | 24L061 | 31/12/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 24J243 | Tampão 1 24J251 | 24J243 | 30/11/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 25B130 | Tampão 1 25B138 | 25B134 | 30/06/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 25D050 | Tampão 1 25D058 | 25D054 | 30/06/2026 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 25J082 | Tampão 1 25J090 | 25J086 | 31/10/2027 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 25L041 | Tampão 1 25L049 | 25L045 | 31/12/2027 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 26A032 | Tampão 1 26A040 | 26A036 | 31/01/2028 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 26A155 | Tampão 1 26A156 | 26A161 | 31/03/2028 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 26C203 | Tampão 1 26C202 | 26C207 | 30/04/2028 |
| Imuno-Rápido Tipagem Sanguínea ABO&RH Tira Teste 26D151 | Tampão 1 26D150 | 26D155 | 31/05/2028 |
| W-Check – Tira de Ácido Úrico Tira Teste 26D151 | 26D142 | 31/05/2027 |
| W-Check – Tira de Creatinina Tira Teste 26D010 | 26D144 | 31/10/2026 |
| W-Check – Tira de Glicose Tira Teste 26D009 | 26D143 | 31/01/2028 |
For more information, access the exclusive channel of the Certificação Lote a Lote and speak with the specialist for this solution. 
(21) 98258-0033
(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.
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