| Família Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)
82444370260 |
Adenovirus |
II |
Enzytec Biotecnologia Ltda. |
01/09/2025 |
Valid |
| Família RSV Antigen Fluorescent Rapid Test Cassette (Swab)
82444370261 |
Respiratory syncytial virus (RSV) |
II |
Enzytec Biotecnologia Ltda. |
01/09/2025 |
Valid |
| Família RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)
82444370262 |
Combined parameters in one product - class II |
II |
Enzytec Biotecnologia Ltda. |
01/09/2025 |
Valid |
| Teste Rápido de SARS-CoV-2 GlobalX
82568320012 |
Coronavirus |
III |
GLOBALX PHARMA LTDA. |
04/08/2025 |
Until 04/08/2035 |
| HIV 1/2 Tri-line Rapid Test Device (Whole Blood/Serum/Plasma)
82444370245 |
Antibody to human immunodeficiency virus type 1, type 2 and type 1 group O (HIV) |
IV |
Enzytec Biotecnologia Ltda. |
26/05/2025 |
Until 26/05/2035 |
| Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370240 |
Dengue |
III |
Enzytec Biotecnologia Ltda. |
28/04/2025 |
Until 28/04/2035 |
| Human Papillomavirus (23 types) Genotyping Kit (Melt-Fluorescence PCR)
82444370225 |
Human papillomavirus (HPV) |
III |
Enzytec Biotecnologia Ltda. |
22/04/2025 |
Until 22/04/2035 |
| CRP Quantitative Test Kit (Time-Resolved FIA)
82444370223 |
High-sensitivity C-reactive protein (hs-CRP) |
II |
Enzytec Biotecnologia Ltda. |
07/04/2025 |
Valid |
| D-Dimer Quantitative Test Kit (Time-Resolved FIA)
82444370224 |
D-dimer |
III |
Enzytec Biotecnologia Ltda. |
07/04/2025 |
Until 07/04/2035 |
| NT-proBNP Quantitative Test Kit (Time-Resolved FIA)
82444370216 |
Human brain natriuretic peptide (BNP) |
III |
Enzytec Biotecnologia Ltda. |
31/03/2025 |
Until 31/03/2035 |
| cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)
82444370217 |
Combined parameters in one product - class III |
III |
Enzytec Biotecnologia Ltda. |
31/03/2025 |
Until 31/03/2035 |
| Teste Rápido em Cassete de HIV 1/2
82568320011 |
HIV-1/HIV-2 nucleic acid |
IV |
GLOBALX PHARMA LTDA. |
31/03/2025 |
Until 31/03/2035 |
| HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370201 |
HIV-1/HIV-2 antigen/antibody |
IV |
Enzytec Biotecnologia Ltda. |
24/02/2025 |
Until 24/02/2035 |
| HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370202 |
Hepatitis B surface antigen (HBsAg) |
IV |
Enzytec Biotecnologia Ltda. |
24/02/2025 |
Until 24/02/2035 |
| Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370204 |
Treponema pallidum total antibodies |
IV |
Enzytec Biotecnologia Ltda. |
24/02/2025 |
Until 24/02/2035 |
| Fecal Occult Blood Rapid Test Cassette (Feces)
82444370198 |
Fecal occult blood |
III |
Enzytec Biotecnologia Ltda. |
17/02/2025 |
Until 17/02/2035 |
| OG-P960 Real-time PCR system
82444370200 |
Nucleic acid analyzer |
II |
Enzytec Biotecnologia Ltda. |
17/02/2025 |
Valid |
| HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) (Cassette)
82444370191 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
Enzytec Biotecnologia Ltda. |
10/02/2025 |
Until 10/02/2035 |
| cTnI Quantitative Test Kit (Time-Resolved FIA)
82444370192 |
Troponin |
III |
Enzytec Biotecnologia Ltda. |
10/02/2025 |
Until 10/02/2035 |
| Coronavirus Ag Teste Rápido em Cassete (Swab)
82444370174 |
Coronavirus |
III |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Until 27/01/2035 |
| Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370175 |
Prostate-specific antigen (PSA) |
III |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Until 27/01/2035 |
| Viral Nucleic Acid Extraction Kit (Magnetic Beads)
82444370182 |
Buffers, diluents and other solutions for laboratory analysis |
I |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Valid |
| Nucleic Acid Extraction or Purification Kit
82444370183 |
Buffers, diluents and other solutions for laboratory analysis |
I |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Valid |
| Disposable Cervical Sampling Kit
82444370188 |
Container or material for collection, storage or transport of biological samples |
I |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Valid |
| OG-N32 Nucleic Acid Purification System
82444370189 |
Sample preparation and processing instrument - pre-analytical phase |
I |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Valid |
| Disposable Virus Sampling Tube
82444370190 |
Container or material for collection, storage or transport of biological samples |
I |
Enzytec Biotecnologia Ltda. |
27/01/2025 |
Valid |
| Teste Rápido em cassete de HCV GlobalX OG
82568320008 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
GLOBALX PHARMA LTDA. |
27/01/2025 |
Until 27/01/2035 |
| Teste Rápido em Cassete de HBsAg GlobalX OG
82568320006 |
Hepatitis B surface antigen (HBsAg) |
IV |
GLOBALX PHARMA LTDA. |
20/01/2025 |
Until 20/01/2035 |
| Teste Rápido em cassete de Sífilis GlobalX OG
82568320007 |
Treponema pallidum IgG/IgM |
IV |
GLOBALX PHARMA LTDA. |
20/01/2025 |
Until 20/01/2035 |
| Dengue NS1 Ag Plus Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370171 |
Dengue |
III |
Enzytec Biotecnologia Ltda. |
06/01/2025 |
Until 06/01/2035 |
| PCT Quantitative Test Kit (Time-Resolved FIA)
82444370169 |
Procalcitonin (PCT) |
III |
Enzytec Biotecnologia Ltda. |
30/12/2024 |
Until 30/12/2034 |
| Família Autoteste pH Vaginal
80113770052 |
Self-test for vaginal pH |
II |
ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP |
23/12/2024 |
Valid |
| Analisador Quantitativo de Imunofluorescência OG-G200
82444370139 |
Immunoassay instrument |
II |
Enzytec Biotecnologia Ltda. |
16/09/2024 |
Valid |
| TSH Quantitative Test Kit (Time-Resolved FIA)
82444370129 |
Thyroid-stimulating hormone (TSH) |
II |
Enzytec Biotecnologia Ltda. |
02/09/2024 |
Valid |
| HbA1c Quantitative Test Kit (Time-Resolved FIA)
82444370130 |
Glycated hemoglobin (HbA1c) |
II |
Enzytec Biotecnologia Ltda. |
02/09/2024 |
Valid |
| Vitamin D Quantitative Test Kit (Time-Resolved FIA)
82444370131 |
Vitamin D |
II |
Enzytec Biotecnologia Ltda. |
02/09/2024 |
Valid |
| Beta-HCG Quantitative Test Kit (Time-Resolved FIA)
82444370134 |
Beta human chorionic gonadotropin (beta-hCG) |
II |
Enzytec Biotecnologia Ltda. |
02/09/2024 |
Valid |
| FT4 Quantitative Test Kit (Time-Resolved FIA)
82444370124 |
Free thyroxine (FT4) |
II |
Enzytec Biotecnologia Ltda. |
26/08/2024 |
Valid |
| T4 Quantitative Test Kit (Time-Resolved FIA)
82444370126 |
Thyroxine (T4) |
II |
Enzytec Biotecnologia Ltda. |
26/08/2024 |
Valid |
| Autoteste de Gravidez Proxima
81692610293 |
Self-test for human chorionic gonadotropin (hCG) |
II |
VYTTRA DIAGNOSTICOS S.A. |
22/07/2024 |
Valid |
| Free T3 Quantitative Test Kit (Time-Resolved FIA)
82444370118 |
Free triiodothyronine (FT3) |
II |
Enzytec Biotecnologia Ltda. |
22/07/2024 |
Valid |
| T3 Quantitative Test Kit (Time-Resolved FIA)
82444370119 |
Triiodothyronine (T3) |
II |
Enzytec Biotecnologia Ltda. |
22/07/2024 |
Valid |
| One Step Pregnancy Test Strip (Urine/Serum)
82444370102 |
Total human chorionic gonadotropin (hCG) |
II |
Enzytec Biotecnologia Ltda. |
20/05/2024 |
Valid |
| Familia de Autoteste de Gravidez Proxima - Digital
81692610285 |
Self-test for human chorionic gonadotropin (hCG) |
II |
VYTTRA DIAGNOSTICOS S.A. |
03/07/2023 |
Valid |
| COVID-19 IgG/IgM Rapid Test Cassette
10246810333 |
Coronavirus |
III |
LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPP |
24/08/2020 |
Until 24/08/2030 |
| COVID-19 IgG/IgM Cassete de Teste Rápido (Total Sangue/Soro/Plasma)
81535830003 |
Coronavirus |
III |
UBUNTU MED IMPORTADORA E DISTRIBUIDORA DE PRODUTOS PARA SAUDE LTDA - ME |
28/05/2020 |
Until 28/05/2030 |