| LAL - Detecção de Endotoxinas
80680429004 |
Endotoxin detection materials |
II |
BIO BRASIL BIOTECNOLOGIA LTDA |
15/04/2021 |
Valid |
| Taffix™ Nasus Nasal Spray
80680429003 |
Not yet published |
II |
Not yet published |
08/04/2021 |
Cancelled 13/04/2021 |
| TAFFIX NASUS NASAL SPRAY
80680429001 |
Not yet published |
II |
Not yet published |
04/02/2021 |
Cancelled 01/03/2021 |
| Painel Respiratório I – EasyPLEX
80680420127 |
Combined parameters in one product - class III |
III |
BIO BRASIL BIOTECNOLOGIA LTDA |
24/08/2026 |
Until 24/08/2036 |
| HPV 16,18, HR Genotyping – EasyPLEX
80680420126 |
Human papillomavirus (HPV) |
III |
BIO BRASIL BIOTECNOLOGIA LTDA |
22/06/2026 |
Until 22/06/2036 |
| TIRA DE URINA DIRUI H13-Cr
80680420125 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
25/05/2026 |
Valid |
| Analisador de Urina (H-1800)
80680420124 |
Urine analyzer |
II |
DIRUI INDUSTRIAL CO. LTD |
18/05/2026 |
Valid |
| TIRA DE URINA DIRUI H14-Ca
80680420123 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
18/05/2026 |
Valid |
| TIRA DE URINA DIRUI FUS-14Ca (II)
80680420122 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
11/05/2026 |
Valid |
| TIRA DE URINA DIRUI FUS-13Cr (II)
80680420121 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
04/05/2026 |
Valid |
| EASY EXTRACT – Kit de Extração-Purificação de DNA/RNA
80680420120 |
Buffers, diluents and other solutions for laboratory analysis |
I |
BIO BRASIL BIOTECNOLOGIA LTDA |
22/04/2026 |
Valid |
| SINGLE SWAB SNAPSURE – COLETOR DE AMOSTRAS BIOLÓGICAS
80680420119 |
Container or material for collection, storage or transport of biological samples |
I |
BIO BRASIL BIOTECNOLOGIA LTDA |
22/04/2026 |
Valid |
| TIRA DE URINA DIRUI FUS-12MA (II)
80680420118 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
22/04/2026 |
Valid |
| Analisador de Sedimento Urinário (FUS-560)
80680420117 |
Urine analyzer |
II |
DIRUI INDUSTRIAL CO. LTD |
13/04/2026 |
Valid |
| TIRA DE URINA DIRUI FUS-11MA (II)
80680420116 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
13/04/2026 |
Valid |
| TIRA DE URINA DIRUI FUS-11(II)
80680420115 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
13/04/2026 |
Valid |
| EASYPLEX SPIN EXTRACT PLUS RNA/DNA – Reagente de Extração
80680420114 |
Buffers, diluents and other solutions for laboratory analysis |
I |
BIO BRASIL BIOTECNOLOGIA LTDA |
06/04/2026 |
Valid |
| Determinand Cleaning Liquid
80680420113 |
Buffers, diluents and other solutions for laboratory analysis |
I |
DIRUI INDUSTRIAL CO. LTD |
18/02/2026 |
Valid |
| UA DYE
80680420112 |
Cytological stains |
I |
DIRUI INDUSTRIAL CO. LTD |
12/01/2026 |
Valid |
| EASYPLEX SPIN EXTRACT RNA/DNA – Reagente de Extração
80680420111 |
Buffers, diluents and other solutions for laboratory analysis |
I |
BIO BRASIL BIOTECNOLOGIA LTDA |
22/12/2025 |
Valid |
| Painel Glicose e Lipídio
80680420110 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
09/06/2025 |
Valid |
| DRG ESTRONA – ELISA
80680420109 |
Estrone |
II |
DRG INTERNATIONAL, INC. |
28/04/2025 |
Valid |
| Painel Função Renal e Hepática
80680420108 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
07/04/2025 |
Valid |
| Painel Função Hepática
80680420107 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
05/03/2025 |
Valid |
| Painel Química Geral IV
80680420106 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
05/03/2025 |
Valid |
| Painel Química Geral I
80680420105 |
Combined parameters in one product - class II |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
17/02/2025 |
Valid |
| Analisador Químico – Pointcare M4
80680420104 |
Analyzer for general chemistry, hormones, drugs or proteins |
II |
TIANJIN MNCHIP TECHNOLOGIES CO., LTD. |
17/02/2025 |
Valid |
| Família Urine Conductivity Analysis Control
80680420103 |
Electrolytes |
II |
DIRUI INDUSTRIAL CO. LTD |
23/12/2024 |
Valid |
| Família Urine Conductivity Analysis Calibrator
80680420102 |
Electrolytes |
II |
DIRUI INDUSTRIAL CO. LTD |
23/12/2024 |
Valid |
| DRG ESTRADIOL – ELISA
80680420101 |
Estradiol |
II |
DRG INTERNATIONAL, INC. |
23/12/2024 |
Valid |
| DRG ESTRADIOL SALIVAR – ELISA
80680420100 |
Estradiol |
II |
DRG INTERNATIONAL, INC. |
23/12/2024 |
Valid |
| DRG PROGESTERONA SALIVAR – ELISA
80680420099 |
Progesterone |
II |
DRG INTERNATIONAL, INC. |
16/09/2024 |
Valid |
| Sistema de Urinálise MUS 9600
80680420098 |
Urine analyzer |
II |
DIRUI INDUSTRIAL CO. LTD |
08/07/2024 |
Valid |
| DRG TESTOSTERONA SALIVAR – ELISA
80680420097 |
Free testosterone |
II |
DRG INTERNATIONAL, INC. |
28/05/2024 |
Valid |
| DRG ESTRIOL LIVRE – ELISA
80680420096 |
Free estriol |
II |
DRG INTERNATIONAL, INC. |
13/05/2024 |
Valid |
| Sistema Híbrido de Urinálise FUS-3000 Plus
80680420095 |
Urine analyzer |
II |
DIRUI INDUSTRIAL CO. LTD |
22/01/2024 |
Valid |
| Biodetechta PSA
80680420094 |
Prostate-specific antigen (PSA) |
III |
BIO BRASIL BIOTECNOLOGIA LTDA |
08/01/2024 |
Until 08/01/2034 |
| Sistema Híbrido de Urinálise FUS-2000
80680420093 |
Urine analyzer |
II |
DIRUI INDUSTRIAL CO. LTD |
20/11/2023 |
Valid |
| TIRA DE URINA DIRUI H-11
80680420092 |
Urine test strip |
II |
DIRUI INDUSTRIAL CO. LTD |
13/11/2023 |
Valid |
| Kit Veri-Q pan-Dengue virus Detection
80680420091 |
Not yet published |
III |
Not yet published |
02/10/2023 |
Cancelled 28/07/2024 |
| Biodetechta MYO FIA - Mioglobina
80680420090 |
Myoglobin |
III |
BIO BRASIL BIOTECNOLOGIA LTDA |
04/09/2023 |
Until 04/09/2033 |
| Veri-Q COVID-19 Multiplex Detection Kit - nCoV-VM
80680420089 |
Not yet published |
III |
Not yet published |
04/09/2023 |
Cancelled 05/10/2026 |
| Biodetechta PCR
80680420088 |
C-reactive protein (CRP) |
II |
BIO BRASIL BIOTECNOLOGIA LTDA |
21/08/2023 |
Valid |
| Biodetechta Procalcitonina (PCT)
80680420087 |
Not yet published |
II |
Not yet published |
14/08/2023 |
Cancelled 09/06/2025 |
| Biodetechta NT-proBNP FIA
80680420086 |
Human brain natriuretic peptide (BNP) |
III |
BIO BRASIL BIOTECNOLOGIA LTDA |
31/07/2023 |
Until 31/07/2033 |
| Biodetechta Adenovírus
80680420085 |
Adenovirus |
II |
BIO BRASIL BIOTECNOLOGIA LTDA |
10/07/2023 |
Valid |
| DRG LEPITINA – ELISA
80680420084 |
Leptin |
II |
DRG INTERNATIONAL, INC. |
29/05/2023 |
Valid |
| DRG PROGESTERONA – ELISA
80680420083 |
Progesterone |
II |
DRG INSTRUMENTS GMBH |
22/05/2023 |
Valid |
| DRG TESTOSTERONA – ELISA
80680420082 |
Testosterone |
II |
DRG INSTRUMENTS GMBH |
22/05/2023 |
Valid |
| DRG CORTISOL – ELISA
80680420081 |
Cortisol/cortisone |
II |
DRG INSTRUMENTS GMBH |
10/04/2023 |
Valid |