LABTEST DIAGNOSTICA S/A
Brazilian registration holder · CNPJ 16.516.296/0001-38
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511registrations
281currently valid
20manufacturers
136device types
1994first registration
77class I
284class II
66class III
35class IV
49old classification
Registrations (page 4 of 11, highest registration number first)
| Product | Device type | Class | Manufacturer | Published | Status |
|---|---|---|---|---|---|
| SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)
10009010362 |
Not yet published | III | Not yet published | 05/10/2020 | Cancelled 26/12/2022 |
| COVID-19 Ag Rapid Test
10009010361 |
Coronavirus | III | LABTEST DIAGNOSTICA S/A | 24/09/2020 | Until 24/09/2030 |
| Anti SARS-CoV-2 IgM/IgG Rapid Test
10009010360 |
Coronavirus | III | LABTEST DIAGNOSTICA S/A | 08/09/2020 | Until 08/09/2030 |
| Lab Rapid HCV
10009010359 |
Total antibody to hepatitis C virus (anti-HCV) | IV | LABTEST DIAGNOSTICA S/A | 10/08/2020 | Until 10/08/2030 |
| Lab Rapid Syphilis
10009010358 |
Treponema pallidum IgG/IgM | IV | LABTEST DIAGNOSTICA S/A | 10/08/2020 | Until 10/08/2030 |
| DETECT SARS-CoV-2 RT-PCR
10009010357 |
Coronavirus | III | LABTEST DIAGNOSTICA S/A | 27/04/2020 | Until 27/04/2030 |
| Anti COVID-19 IgG/IgM Rapid Test
10009010356 |
Not yet published | III | Not yet published | 23/03/2020 | Cancelled 24/02/2025 |
| Família LABMAX i
10009010355 |
Analyzer for general chemistry, hormones, drugs or proteins | II | TOKYO BOEKI MEDISYS, INC. | 27/01/2020 | Valid |
| i15 Blood Gas and Chemistry Analyzer
10009010354 |
Analyzer for blood gases, ions or pH | II | EDAN INSTRUMENTS, INC. | 18/11/2019 | Valid |
| Família Blood Gas and Electrolyte Controls
10009010353 |
Not yet published | II | Not yet published | 04/11/2019 | Cancelled 24/11/2025 |
| Test Cartridge BG10
10009010352 |
Not yet published | II | Not yet published | 04/11/2019 | Cancelled 24/11/2025 |
| Calibrant Fluid Pack
10009010351 |
Not yet published | II | Not yet published | 04/11/2019 | Cancelled 24/11/2025 |
| UriAction 10 SD
10009010350 |
Not yet published | II | Not yet published | 09/09/2019 | Cancelled 15/07/2024 |
| Família Audmax
10009010349 |
Analyzer for general chemistry, hormones, drugs or proteins | II | DIRUI INDUSTRIAL CO. LTD | 29/07/2019 | Valid |
| CMV M
10009010348 |
Not yet published | IV | Not yet published | 25/02/2019 | Cancelled 15/07/2024 |
| Família PCR Ultra Turbiquest Max
10009010347 |
High-sensitivity C-reactive protein (hs-CRP) | II | LABTEST DIAGNOSTICA S/A | 21/01/2019 | Valid |
| Família PCR Turbiquest Max
10009010346 |
C-reactive protein (CRP) | II | LABTEST DIAGNOSTICA S/A | 29/10/2018 | Valid |
| Família Látex FR
10009010345 |
Rheumatoid factor | II | LABTEST DIAGNOSTICA S/A | 24/09/2018 | Valid |
| Família FR Turbiquest Max
10009010344 |
Rheumatoid factor | II | LABTEST DIAGNOSTICA S/A | 24/09/2018 | Valid |
| Toxo M
10009010343 |
Not yet published | IV | Not yet published | 02/07/2018 | Cancelled 14/09/2026 |
| Látex AEO
10009010342 |
Antistreptolysin | II | LABTEST DIAGNOSTICA S/A | 25/06/2018 | Valid |
| Família PCR Turbiquest Wide Range
10009010341 |
C-reactive protein (CRP) | II | LABTEST DIAGNOSTICA S/A | 18/06/2018 | Valid |
| HDL SD
10009010340 |
High-density lipoprotein (HDL) | II | LABTEST DIAGNOSTICA S/A | 05/02/2018 | Valid |
| DPP Micro Reader
10009010339 |
Not yet published | II | Not yet published | 08/01/2018 | Cancelled 26/12/2022 |
| Potássio Enzimático
10009010338 |
Potassium | II | LABTEST DIAGNOSTICA S/A | 02/01/2018 | Valid |
| Sódio Enzimático
10009010337 |
Not yet published | II | Not yet published | 20/03/2017 | Cancelled 26/12/2022 |
| DPP® Rapid Test Sífilis
10009010336 |
Not yet published | IV | Not yet published | 07/11/2016 | Cancelled 26/12/2022 |
| DPP® Rapid Test HIV 1/2
10009010335 |
Not yet published | IV | Not yet published | 07/11/2016 | Cancelled 26/12/2022 |
| Betatest
10009010334 |
Beta human chorionic gonadotropin (beta-hCG) | II | LABTEST DIAGNOSTICA S/A | 10/10/2016 | Valid |
| LDL
10009010333 |
Low-density lipoprotein (LDL) | II | LABTEST DIAGNOSTICA S/A | 18/07/2016 | Valid |
| Calibra Ferritina Turbiquest
10009010332 |
Ferritin | II | LABTEST DIAGNOSTICA S/A | 18/07/2016 | Valid |
| Fibrinogênio
10009010331 |
Fibrinogen | II | LABTEST DIAGNOSTICA S/A | 18/07/2016 | Valid |
| RUBÉOLA G
10009010330 |
Not yet published | III | Not yet published | 18/07/2016 | Cancelled 15/07/2024 |
| Toxo G
10009010329 |
Not yet published | IV | Not yet published | 18/07/2016 | Cancelled 13/10/2025 |
| APTT
10009010328 |
Not yet published | III | Not yet published | 18/07/2016 | Cancelled 24/11/2025 |
| CMV G
10009010327 |
Not yet published | IV | Not yet published | 18/07/2016 | Cancelled 15/07/2024 |
| SDH Diluente AV
10009010326 |
Buffers, diluents and other solutions for laboratory analysis | I | LABTEST DIAGNOSTICA S/A | 04/07/2016 | Valid |
| HDL
10009010325 |
High-density lipoprotein (HDL) | II | LABTEST DIAGNOSTICA S/A | 04/07/2016 | Valid |
| DS Rapid Test HIV
10009010324 |
Not yet published | IV | Not yet published | 27/06/2016 | Cancelled 26/12/2022 |
| SDH Lisante AV
10009010323 |
Lysis solution | I | LABTEST DIAGNOSTICA S/A | 20/06/2016 | Valid |
| Qualitrol Ferritina IgE
10009010322 |
Combined parameters in one product - class II | II | LABTEST DIAGNOSTICA S/A | 23/05/2016 | Valid |
| PT
10009010321 |
Not yet published | III | Not yet published | 23/05/2016 | Cancelled 24/11/2025 |
| Solução Alcalina Labmax 400/560
10009010320 |
Not yet published | I | Not yet published | 03/11/2015 | Cancelled 07/07/2025 |
| Solução Ácida Labmax 400/560
10009010319 |
Not yet published | I | Not yet published | 03/11/2015 | Cancelled 07/07/2025 |
| Condicionador de Sódio ISE
10009010318 |
Not yet published | II | Not yet published | 05/10/2015 | Cancelled 01/07/2024 |
| Família Qualitrol Hemostasis
10009010317 |
Combined parameters in one product - class III | III | LABTEST DIAGNOSTICA S/A | 21/09/2015 | Until 21/09/2035 |
| Diluente para Urina ISE
10009010316 |
Not yet published | I | Not yet published | 14/09/2015 | Cancelled 01/07/2024 |
| Padrão ISE A+B
10009010315 |
Not yet published | II | Not yet published | 14/09/2015 | Cancelled 01/07/2024 |
| Solução de Limpeza Intensa ISE
10009010314 |
Not yet published | I | Not yet published | 14/09/2015 | Cancelled 15/07/2024 |
| Labmax ISE Controle - Ampola
10009010313 |
Not yet published | II | Not yet published | 14/09/2015 | Cancelled 01/07/2024 |