| Teste Rápido OnSite COVID-19 + Influenza A/B Ag
80524900081 |
Combined parameters - respiratory panel |
III |
CTK BIOTECH, INC. |
22/04/2026 |
Until 22/04/2036 |
| OnSite Covid-19 Ag Autoteste
80524900080 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
CTK BIOTECH, INC. |
15/08/2022 |
Until 15/08/2032 |
| Teste Rápido OnSite Dengue IgG
80524900079 |
Dengue |
III |
CTK BIOTECH, INC. |
22/02/2021 |
Until 22/02/2031 |
| DISCOS DE REAGENTES LIOFILIZADOS DE EMERGÊNCIA CLÍNICA
80524900078 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD |
28/01/2021 |
Valid |
| DISCOS DE REAGENTES LIOFILIZADOS DE ELETRÓLITOS
80524900077 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD |
28/01/2021 |
Valid |
| Teste Rápido OnSite Covid-19 Ag
80524900076 |
Coronavirus |
III |
CTK BIOTECH, INC. |
21/12/2020 |
Until 21/12/2030 |
| POINTCARE M4
80524900075 |
Analyzer for general chemistry, hormones, drugs or proteins |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD |
21/09/2020 |
Valid |
| LEITOR DE TESTE RÁPIDO ALTA - RTR-1
80524900074 |
Immunoassay instrument |
II |
CTK BIOTECH, INC. |
31/08/2020 |
Valid |
| DISCOS DE REAGENTES LIOFILIZADOS DE QUÍMICA I
80524900073 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD |
31/08/2020 |
Valid |
| CoproStrip - C. difficile GDH + Toxin A + Toxin B
80524900072 |
Not yet published |
II |
Not yet published |
20/07/2020 |
Cancelled 09/06/2025 |
| Teste Rápido OnSite™ COVID-19 IgG/IgM
80524900071 |
Coronavirus |
III |
CTK BIOTECH, INC. |
03/04/2020 |
Until 03/04/2030 |
| Aridia ZIKA, DENGUE E CHIK RT-PCR
80524900070 |
Chikungunya, dengue and Zika |
IV |
BEIJING GENESE BIOTECH, INC. |
08/04/2019 |
Until 08/04/2029 |
| Aridia DENGUE RT-PCR
80524900069 |
Dengue |
III |
BEIJING GENESEE BIOTECH INC |
10/12/2018 |
Until 10/12/2028 |
| Aridia Sorotipagem DENGUE RT-PCR
80524900068 |
Dengue |
III |
BEIJING GENESEE BIOTECH INC. |
10/12/2018 |
Until 10/12/2028 |
| Aridia ZIKA RT-PCR
80524900067 |
Not yet published |
IV |
Not yet published |
06/08/2018 |
Cancelled 14/09/2026 |
| Lancetas de Segurança
80524900066 |
Lancets |
II |
NINGBO MEDSUN MEDICAL CO., LTD. |
09/07/2018 |
Valid |
| Aridia INFLUENZA A/B e VSR RT-PCR
80524900065 |
Not yet published |
III |
Not yet published |
11/06/2018 |
Cancelled 14/09/2026 |
| Aridia CHIKUNGUNYA RT-PCR
80524900064 |
Not yet published |
III |
Not yet published |
04/06/2018 |
Cancelled 14/09/2026 |
| Teste Elisa RecombiLISA Zika IgM
80524900063 |
Not yet published |
IV |
Not yet published |
04/12/2017 |
Cancelled 14/09/2026 |
| TESTE RÁPIDO ONSITE CHLAMYDIA Ag
80524900062 |
Not yet published |
IV |
Not yet published |
04/09/2017 |
Cancelled 27/04/2026 |
| TESTE RÁPIDO ONSITE CHAGAS Ab COMBO
80524900061 |
Trypanosoma cruzi IgG |
IV |
CTK BIOTECH, INC. |
17/07/2017 |
Until 17/07/2027 |
| Teste Rápido Onsite Tifóide IgG/IgM Combo
80524900060 |
Not yet published |
II |
Not yet published |
10/07/2017 |
Cancelled 09/06/2025 |
| TESTE RÁPIDO ONSITE MALÁRIA Pf/Pan Ag
80524900059 |
Plasmodium antigen (multiple species) |
IV |
CTK BIOTECH, INC. |
19/06/2017 |
Until 19/06/2027 |
| TESTE RÁPIDO ONSITE LEISHIMANIA IGG/IgM Combo
80524900058 |
Not yet published |
III |
Not yet published |
12/06/2017 |
Cancelled 27/04/2026 |
| TESTE RÁPIDO ONSITE ROTA-ADENO Ag
80524900057 |
Rotavirus |
II |
CTK BIOTECH, INC. |
29/05/2017 |
Valid |
| Tests Rápido Onsite Filariose IgG/IgM Combo
80524900056 |
Not yet published |
II |
Not yet published |
29/05/2017 |
Cancelled 27/04/2026 |
| Teste Rápido Onsite HIV 1/2 Ab Plus Combo
80524900055 |
HIV-1/HIV-2 antibody |
IV |
CTK BIOTECH, INC. |
08/05/2017 |
Until 08/05/2027 |
| RecombiLISA Dengue Ag
80524900054 |
Not yet published |
III |
Not yet published |
08/05/2017 |
Cancelled 27/04/2026 |
| Teste Rápido Onsite Leptospirose IgG/IgM Combo
80524900053 |
Leptospira spp. |
III |
CTK BIOTECH, INC. |
24/04/2017 |
Until 24/04/2027 |
| TESTE RÁPIDO ONSITE SÍFILIS Ab COMBO
80524900052 |
Treponema pallidum total antibodies |
IV |
CTK BIOTECH, INC. |
06/02/2017 |
Until 06/02/2027 |
| TESTE RÁPIDO ONSITE STREP A
80524900051 |
Streptococcus |
III |
CTK BIOTECH, INC. |
09/01/2017 |
Until 09/01/2037 |
| TESTE RÁPIDO ONSITE TB IgG/IgM Combo
80524900050 |
Mycobacterium |
III |
CTK BIOTECH, INC. |
28/11/2016 |
Until 28/11/2026 |
| Teste Rápido de Gravidez HCG Soro/Urina
80524900049 |
Total human chorionic gonadotropin (hCG) |
II |
JEI DANIEL (JD) BIOTECH CORP. |
28/11/2016 |
Valid |
| TESTE RÁPIDO ONSITE HSV-2 IgG/IgM
80524900048 |
Herpes simplex virus (HHV-2) |
III |
CTK BIOTECH, INC. |
24/10/2016 |
Until 24/10/2036 |
| TESTE RÁPIDO ONSITE HSV-1 IgG/IgM
80524900047 |
Herpes simplex virus (HHV-1) |
II |
CTK BIOTECH, INC. |
24/10/2016 |
Valid |
| TESTE RÁPIDO ONSITE HAV IgG/IgM
80524900046 |
Hepatitis A virus (HAV) |
III |
CTK BIOTECH, INC. |
17/10/2016 |
Until 17/10/2036 |
| Teste Rápido Onsite PSA Semi-Quantitativo
80524900045 |
Prostate-specific antigen (PSA) |
III |
CTK BIOTECH, INC. |
17/10/2016 |
Until 17/10/2036 |
| TESTE RÁPIDO ONSITE MALÁRIA Pf/Pv Ab COMBO
80524900044 |
Plasmodium total antibodies (multiple species) |
IV |
CTK BIOTECH, INC. |
17/10/2016 |
Until 17/10/2036 |
| TESTE RAPIDO ONSITE H. PYLORI Ag
80524900043 |
Helicobacter pylori |
II |
CTK BIOTECH, INC. |
10/10/2016 |
Valid |
| TESTE RÁPIDO ONSITE HBSAG COMBO
80524900042 |
Hepatitis B surface antigen (HBsAg) |
IV |
CTK BIOTECH, INC. |
03/10/2016 |
Until 03/10/2036 |
| TESTE RÁPIDO ONSITE HCV Ab PLUS COMBO
80524900041 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
CTK BIOTECH, INC. |
05/09/2016 |
Until 05/09/2036 |
| TESTE RÁPIDO ONSITE INFLUENZA A/B
80524900040 |
Influenza A and B viruses |
III |
CTK BIOTECH, INC. |
15/08/2016 |
Until 15/08/2036 |
| Teste Rápido OnSite Sangue Oculto-FOB
80524900039 |
Fecal occult blood |
III |
CTK BIOTECH, INC. |
28/12/2015 |
Until 28/12/2035 |
| Teste Rápido OnSite Rubéola IgG/IgM
80524900038 |
Rubella virus |
III |
CTK BIOTECH, INC. |
28/12/2015 |
Until 28/12/2035 |
| Teste Rápido OnSite Rotavírus Ag
80524900037 |
Rotavirus |
II |
CTK BIOTECH, INC. |
28/12/2015 |
Valid |
| Teste Rápido OnSite Troponina I Combo
80524900036 |
Troponin |
III |
CTK BIOTECH, INC. |
28/12/2015 |
Until 28/12/2035 |
| Teste Rápido OnSite Duo CMV IgG/IgM
80524900035 |
Cytomegalovirus (CMV) IgG/IgM |
IV |
CTK BIOTECH, INC. |
14/12/2015 |
Until 14/12/2035 |
| Teste Rápido OnSite Toxo IgG/IgM Combo
80524900034 |
Toxoplasma gondii IgG/IgM |
IV |
CTK BIOTECH, INC. |
14/12/2015 |
Until 14/12/2035 |
| Teste Rápido OnSite Dengue IgG/IgM3.0 Combo
80524900033 |
Dengue |
III |
CTK BIOTECH, INC. |
07/12/2015 |
Until 07/12/2035 |
| Teste Rápido OnSite Dengue Ag
80524900032 |
Dengue |
III |
CTK BIOTECH, INC. |
07/12/2015 |
Until 07/12/2035 |