| GeneFinder COVID-19/Flu Antigen Test Nasal
81914040050 |
Combined parameters - respiratory panel |
III |
OSANG HEALTHCARE CO., LTD. |
02/06/2025 |
Until 02/06/2035 |
| GeneFinder-L RV Panel-I RealAmp Kit
81914040049 |
Combined parameters in one product - class III |
III |
OSANG HEALTHCARE CO., LTD. |
31/03/2025 |
Until 31/03/2035 |
| GeneFinder COVID-19/Flu Antigen Test
81914040048 |
Combined parameters - respiratory panel |
III |
OSANG HEALTHCARE CO., LTD. |
02/12/2024 |
Until 02/12/2034 |
| GeneFinder Dengue NS1 Antigen Rapid Test
81914040047 |
Dengue |
III |
OSANG HEALTHCARE CO., LTD. |
18/11/2024 |
Until 18/11/2034 |
| GeneFinder-L™ Arbovirus Panel-I RealAmp Kit
81914040046 |
Chikungunya, dengue, yellow fever, Mayaro, Oropouche and Zika |
IV |
OSANG HEALTHCARE CO., LTD. |
13/11/2024 |
Until 13/11/2034 |
| GeneFinder HPV-HR RealAmp Kit
81914040045 |
Human papillomavirus (HPV) |
III |
OSANG HEALTHCARE CO., LTD. |
07/10/2024 |
Until 07/10/2034 |
| GeneFinder Dengue IgG/IgM Rapid Test
81914040044 |
Dengue |
III |
OSANG HEALTHCARE CO., LTD. |
26/08/2024 |
Until 26/08/2034 |
| ELEMENT MULTI SOLUÇAO CONTROLE DE GLICOSE - ALTO, NORMAL E BAIXO
81914040043 |
Glucose - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
08/07/2024 |
Valid |
| Element Multi - Tiras de teste de Glicose no sangue
81914040042 |
Glucose - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
08/07/2024 |
Valid |
| Element Multi - Sistema de medição de Glicose e Perfil Lipídico
81914040041 |
Glucose and lipid profile instrument - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
08/07/2024 |
Valid |
| GENEFINDER DENV/ZIKV/CHIKV REAL AMP KIT
81914040040 |
Chikungunya, dengue and Zika |
IV |
OSANG HEALTHCARE CO., LTD. |
14/02/2024 |
Until 14/02/2034 |
| GeneFinder DENV Typing RealAmp Kit
81914040039 |
Dengue |
III |
OSANG HEALTHCARE CO., LTD. |
14/02/2024 |
Until 14/02/2034 |
| Element Multi – Solução Controle de Colesterol Total
81914040038 |
Self-test for cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
05/02/2024 |
Valid |
| Element Multi - Solução Controle de Triglicerídeos
81914040037 |
Self-test for triglycerides |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element Multi – Solução Controle de HDL
81914040036 |
Self-test for cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element Multi - Tiras de teste de triglicerídeos
81914040035 |
Self-test for triglycerides |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element Multi - Tiras de teste de Colesterol Total
81914040034 |
Self-test for cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element Multi - Tiras de teste de Colesterol HDL
81914040033 |
Self-test for cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element Multi - Tiras de teste de perfil lipídico
81914040032 |
Combined parameters in one product - class II |
II |
OSANG HEALTHCARE CO., LTD. |
22/01/2024 |
Valid |
| Element - Sistema de medição de Perfil Lipídico
81914040031 |
Not yet published |
II |
Not yet published |
22/01/2024 |
Cancelled 30/09/2024 |
| GeneFinder MPXV RealAmp Kit
81914040030 |
Orthopoxvirus |
III |
OSANG HEALTHCARE CO., LTD. |
13/11/2023 |
Until 13/11/2033 |
| Genefinder STD I (CT/NG/UU) Multiplex Real-time PCR kit
81914040029 |
Combined parameters in one product - class III |
III |
OSANG HEALTHCARE CO., LTD. |
16/10/2023 |
Until 16/10/2033 |
| Família LipidPro Solução Controle de Glicose - Alto, Normal e Baixo
81914040028 |
Glucose - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
22/05/2023 |
Valid |
| GeneFinder STD II (MG/MH/TV) Multiplex Real-time PCR kit
81914040027 |
Combined parameters in one product - class III |
III |
OSANG HEALTHCARE CO., LTD. |
02/05/2023 |
Until 02/05/2033 |
| Clover A1c Self - Cartucho de Verificação Mensal
81914040026 |
Glycated hemoglobin (HbA1c) |
II |
OSANG HEALTHCARE CO., LTD. |
17/04/2023 |
Valid |
| Clover A1c Self - Cartucho de Verificação Diária
81914040025 |
Glycated hemoglobin (HbA1c) |
II |
OSANG HEALTHCARE CO., LTD. |
17/04/2023 |
Valid |
| LipidPro Solução Controle de Triglicerídeos
81914040024 |
Triglycerides |
II |
OSANG HEALTHCARE CO., LTD. |
13/03/2023 |
Valid |
| LipidPro Solução Controle de Colesterol - HDL
81914040023 |
High-density lipoprotein (HDL) |
II |
OSANG HEALTHCARE CO., LTD. |
13/03/2023 |
Valid |
| LipidPro Solução Controle de Colesterol Total
81914040022 |
Total cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
13/03/2023 |
Valid |
| GeneFinder TB&NTM Multiplex Real time PCR kit
81914040021 |
Combined parameters in one product - class III |
III |
OSANG HEALTHCARE CO., LTD. |
06/03/2023 |
Until 06/03/2033 |
| CLOVER A1c SELF - Cartucho
81914040020 |
Glycated hemoglobin (HbA1c) |
II |
OSANG HEALTHCARE CO., LTD. |
06/02/2023 |
Valid |
| Clover A1c Self - Analisador de Teste
81914040019 |
Glycated hemoglobin (HbA1c) |
II |
UNA MEDIC IMPORTAÇAO E EXPORTAÇAO LTDA |
30/01/2023 |
Valid |
| LipidPro - Tiras de teste de Glicose
81914040018 |
Glucose - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
26/12/2022 |
Valid |
| LipidPro - Sistema de Monitoramento de Perfil Lipidico e Glicose
81914040017 |
Glucose and lipid profile instrument - point-of-care testing (professional) |
II |
OSANG HEALTHCARE CO., LTD. |
26/12/2022 |
Valid |
| LipidPro – Tiras de teste de Perfil Lipídico
81914040016 |
Combined parameters in one product - class II |
II |
OSANG HEALTHCARE CO., LTD. |
22/09/2022 |
Valid |
| LipidPro – Tiras de teste de triglicerídeos
81914040015 |
Triglycerides |
II |
OSANG HEALTHCARE CO., LTD. |
22/09/2022 |
Valid |
| LipidPro – Tiras de teste de Colesterol HDL
81914040014 |
High-density lipoprotein (HDL) |
II |
OSANG HEALTHCARE CO., LTD. |
22/09/2022 |
Valid |
| LipidPro – Tiras de teste de Colesterol Total
81914040013 |
Total cholesterol |
II |
OSANG HEALTHCARE CO., LTD. |
22/09/2022 |
Valid |
| GeneFinder COVID-19 Ag Self Test
81914040012 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
OSANG HEALTHCARE CO., LTD. |
30/03/2022 |
Until 30/03/2032 |
| GeneFinder FLU A&B Real Amp Kit
81914040011 |
Influenza A and B viruses |
III |
OSANG HEALTHCARE CO., LTD. |
28/03/2022 |
Until 28/03/2032 |
| GeneFinder COVID-19 Antigeno test
81914040010 |
Not yet published |
III |
Not yet published |
14/03/2022 |
Cancelled 29/07/2024 |
| GeneFinder COVID-19 Ag Plus AS Rapid test
81914040009 |
Coronavirus |
III |
OSANG HEALTHCARE CO., LTD. |
07/03/2022 |
Until 07/03/2032 |
| GeneFinder COVID-19 Ag Plus
81914040008 |
Coronavirus |
III |
OSANG HEALTHCARE CO., LTD. |
23/08/2021 |
Until 23/08/2031 |
| GeneFinder COVID-19 Flu A&B RealAmp Kit
81914040007 |
Combined parameters - respiratory panel |
III |
OSANG HEALTHCARE CO., LTD. |
12/07/2021 |
Until 12/07/2031 |
| GeneFinder COVID-19 Fast RealAmp Kit
81914040006 |
Coronavirus |
III |
OSANG HEALTHCARE CO., LTD. |
28/06/2021 |
Until 28/06/2031 |
| GeneFinder COVID-19 Ag Rapid Test
81914040005 |
Not yet published |
III |
Not yet published |
28/12/2020 |
Cancelled 29/07/2024 |
| EXTRATOR DE ÁCIDO NUCLEICO
81914040004 |
Sample preparation and processing instrument - pre-analytical phase |
I |
HANWOOL TPC CO., LTD. |
24/09/2020 |
Valid |
| alphaPrep™ KIT DE EXTRAÇÃO DE DNA/RNA VIRAL
81914040003 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ALPHAGENE CO., LTD. |
20/08/2020 |
Valid |
| GeneFinder COVID-19 Plus RealAmp Kit
81914040002 |
Coronavirus |
III |
OSANG HEALTHCARE CO., LTD. |
21/05/2020 |
Until 21/05/2030 |