| C-Reactive Protein Kit (Turbidimetry Method)
80115310316 |
C-reactive protein (CRP) |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| Creatine Kinase Kit (IFCC Method)
80115310315 |
Creatine kinase (CK) |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| Creatinine Kit (Sarcosine Oxidase Method)
80115310314 |
Creatinine |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| HDL-Cholesterol Kit (Direct Method)
80115310313 |
High-density lipoprotein (HDL) |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| LDL-Cholesterol Kit(Direct Method)
80115310312 |
Low-density lipoprotein (LDL) |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| Lipids Calibrator
80115310311 |
Combined parameters in one product - class II |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
24/11/2025 |
Valid |
| Alkaline Phosphatase Kit (IFCC Modified Method)
80115310310 |
Alkaline phosphatase (ALP) |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Uric Acid Kit (Uricase-Peroxidase Method)
80115310309 |
Uric acid |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Glucose Kit (HK Method)
80115310308 |
Glucose |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Specific Proteins Calibrator
80115310307 |
Combined parameters in one product - class II |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Triglycerides Kit (GPO-POD Method)
80115310306 |
Triglycerides |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Total Cholesterol Kit (CHOD-POD Method)
80115310305 |
Total cholesterol |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Glucose Kit (GOD-POD Method)
80115310304 |
Glucose |
II |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
03/11/2025 |
Valid |
| Alfa-1 Antitripsina
80115310303 |
Alpha-1 antitrypsin |
II |
KOVALENT DO BRASIL LTDA |
03/11/2025 |
Valid |
| MyKov U5600
80115310302 |
Urine analyzer |
II |
KOVALENT DO BRASIL LTDA |
22/09/2025 |
Valid |
| Tiras Reagentes para Urinálise (EN 11U)
80115310301 |
Urine test strip |
II |
JILIN LEADING BIO-ENGINEERING CO., LTD. |
15/09/2025 |
Valid |
| EU-50 - Reagente para Sistema Automático de Urinálise
80115310300 |
Buffers, diluents and other solutions for laboratory analysis |
I |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
14/07/2025 |
Valid |
| Família ASO HL
80115310299 |
Antistreptolysin |
II |
KOVALENT DO BRASIL LTDA |
17/02/2025 |
Valid |
| Família ß-Hydroxybutyrate
80115310298 |
Ketones |
II |
DIASYS DIAGNOSTIC SYSTEMS GMBH |
23/09/2024 |
Valid |
| Família Total Bile Acids
80115310297 |
Bile acids |
II |
DIASYS DIAGNOSTIC SYSTEMS GMBH |
22/07/2024 |
Valid |
| K-teste Clamídia
80115310296 |
Chlamydia trachomatis antigen |
IV |
KOVALENT DO BRASIL LTDA |
08/01/2024 |
Until 08/01/2034 |
| MyKov Cleaner Solution
80115310295 |
Not yet published |
I |
Not yet published |
09/10/2023 |
Cancelled 31/03/2025 |
| K-teste Rota/Adeno
80115310294 |
Combined parameters in one product - class II |
II |
KOVALENT DO BRASIL LTDA |
21/08/2023 |
Valid |
| K-teste HCV
80115310293 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
KOVALENT DO BRASIL LTDA |
19/06/2023 |
Until 19/06/2033 |
| Probe Cleanser
80115310292 |
Not yet published |
I |
Not yet published |
29/05/2023 |
Cancelled 31/03/2025 |
| Proteína Total UC
80115310291 |
Total protein |
II |
KOVALENT DO BRASIL LTDA |
15/05/2023 |
Valid |
| K-teste Dengue NS1
80115310290 |
Dengue |
III |
KOVALENT DO BRASIL LTDA |
15/05/2023 |
Until 15/05/2033 |
| K-teste HIV 1/2
80115310289 |
HIV-1/HIV-2 antibody |
IV |
KOVALENT DO BRASIL LTDA |
08/05/2023 |
Until 08/05/2033 |
| K-teste HBsAg
80115310288 |
Hepatitis B surface antigen (HBsAg) |
IV |
KOVALENT DO BRASIL LTDA |
17/04/2023 |
Until 17/04/2033 |
| Família de Soluções para Hematologia M-52
80115310287 |
Lysis solution |
I |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
06/03/2023 |
Valid |
| Família de Soluções para Hematologia M-53
80115310286 |
Lysis solution |
I |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
06/03/2023 |
Valid |
| K-teste Troponina I
80115310285 |
Troponin |
III |
KOVALENT DO BRASIL LTDA |
06/02/2023 |
Until 06/02/2033 |
| K-teste COVID-19 Ag
80115310284 |
Coronavirus |
III |
KOVALENT DO BRASIL LTDA |
30/01/2023 |
Until 30/01/2033 |
| K-teste Covid-19 Ag AUTOTESTE
80115310283 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
KOVALENT DO BRASIL LTDA |
23/01/2023 |
Until 23/01/2033 |
| K -teste COVID-19 / FLU Combo
80115310282 |
Combined parameters - respiratory panel |
III |
KOVALENT DO BRASIL LTDA |
23/01/2023 |
Until 23/01/2033 |
| Família MyKov Cell
80115310281 |
Cell and platelet analyzer or counter |
II |
KOVALENT DO BRASIL LTDA |
23/01/2023 |
Valid |
| K-teste Sangue Oculto (FOB)
80115310280 |
Fecal occult blood |
III |
KOVALENT DO BRASIL LTDA |
19/12/2022 |
Until 19/12/2032 |
| K-teste Beta-HCG
80115310279 |
Beta human chorionic gonadotropin (beta-hCG) |
II |
KOVALENT DO BRASIL LTDA |
27/10/2022 |
Valid |
| LDL-c Direto
80115310278 |
Low-density lipoprotein (LDL) |
II |
KOVALENT DO BRASIL LTDA |
11/08/2022 |
Valid |
| TopKal BICARBONATO
80115310277 |
Not yet published |
II |
Not yet published |
11/08/2022 |
Cancelled 09/06/2025 |
| TopKal PROTEÍNA TOTAL UC
80115310276 |
Total protein |
II |
KOVALENT DO BRASIL LTDA |
11/08/2022 |
Valid |
| FAMÍLIA PCR HL
80115310275 |
C-reactive protein (CRP) |
II |
KOVALENT DO BRASIL LTDA |
14/07/2022 |
Valid |
| FAMILIA MYKOV
80115310274 |
Analyzer for general chemistry, hormones, drugs or proteins |
II |
KOVALENT DO BRASIL LTDA |
03/03/2022 |
Valid |
| SGTi-flex COVID-19 Ag – SELF TEST
80115310273 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
SUGENTECH, INC. |
02/03/2022 |
Until 02/03/2032 |
| SGTi-flex COVID-19 Ag – AUTOTESTE
80115310272 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
KOVALENT DO BRASIL LTDA |
25/02/2022 |
Until 25/02/2032 |
| Família respons 3H Combo pack
80115310271 |
Not yet published |
I |
Not yet published |
30/12/2020 |
Cancelled 27/11/2023 |
| Família respons 5H Combo pack
80115310270 |
Not yet published |
I |
Not yet published |
30/12/2020 |
Cancelled 27/11/2023 |
| Família Control Blood Multilevel 5H
80115310269 |
Not yet published |
II |
Not yet published |
26/11/2020 |
Cancelled 27/11/2023 |
| Família Control Blood Multilevel 3H
80115310268 |
Not yet published |
II |
Not yet published |
26/11/2020 |
Cancelled 27/11/2023 |
| HDL-C Direto
80115310267 |
High-density lipoprotein (HDL) |
II |
KOVALENT DO BRASIL LTDA |
26/11/2020 |
Valid |