| Teste Rápido PSA
82533950052 |
Prostate-specific antigen (PSA) |
III |
GUANGZHOU WONDFO BIOTECH CO. LTD |
26/02/2024 |
Until 26/02/2034 |
| Fast Test hCG H-Plus
82533950051 |
Total human chorionic gonadotropin (hCG) |
II |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
26/02/2024 |
Valid |
| Fast Test mAlb H-Plus
82533950050 |
Albumin |
II |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
26/02/2024 |
Valid |
| Fast Test ß2-MG H-Plus
82533950049 |
Beta-2 microglobulin |
II |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
26/02/2024 |
Valid |
| Solução de Pré-Tratamento de Amostra – MALDI-TOF
82533950048 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
22/01/2024 |
Valid |
| Dengue NS1
82533950047 |
Dengue |
III |
GUANGZHOU WONDFO BIOTECH CO. LTD |
27/11/2023 |
Until 27/11/2033 |
| HIV 1/2 (3 linhas)
82533950046 |
HIV-1/HIV-2 antibody |
IV |
GUANGZHOU WONDFO BIOTECH CO. LTD |
13/11/2023 |
Until 13/11/2033 |
| HIV 1/2 (2 linhas)
82533950045 |
HIV-1/HIV-2 antibody |
IV |
GUANGZHOU WONDFO BIOTECH CO. LTD |
13/11/2023 |
Until 13/11/2033 |
| Lancetador
82533950044 |
Lancing device |
I |
STERILANCE MEDICAL (SUZHOU) INC. |
30/10/2023 |
Valid |
| Controle de Sedimento I
82533950043 |
Urine sediment |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Tira de Urinálise 12I
82533950042 |
Urine test strip |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Controle UDC I
82533950041 |
Combined parameters in one product - class II |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Analisador de Imunocromatografia por Fluorescência - EXR
82533950040 |
Immunoassay instrument |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Calibrador de Sedimento – US I
82533950039 |
Urine sediment |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Tira de Urinálise 11I
82533950038 |
Urine test strip |
II |
ZYBIO INC. |
09/10/2023 |
Valid |
| Troponina I
82533950037 |
Troponin |
III |
GUANGZHOU WONDFO BIOTECH CO. LTD |
02/10/2023 |
Until 02/10/2033 |
| HBsAg
82533950036 |
Hepatitis B surface antigen (HBsAg) |
IV |
GUANGZHOU WONDFO BIOTECH CO. LTD |
18/09/2023 |
Until 18/09/2033 |
| Sistema Hibrido de Urinálise 15I
82533950035 |
Urine analyzer |
II |
ZYBIO INC. |
18/09/2023 |
Valid |
| Fluido de Revestimento I
82533950034 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
18/09/2023 |
Valid |
| Lancetador
82533950033 |
Not yet published |
I |
Not yet published |
18/09/2023 |
Cancelled 02/10/2023 |
| Fast Test Gravidez Semanas Digital
82533950032 |
Self-test for human chorionic gonadotropin (hCG) |
II |
ASSURE TECH. (HANGZHOU) CO., LTD |
11/09/2023 |
Valid |
| Analisador Hematológico - EXZ
82533950031 |
Cell and platelet analyzer or counter |
II |
ZYBIO INC. |
04/09/2023 |
Valid |
| Solução de Limpeza D12 I
82533950030 |
Not yet published |
I |
Not yet published |
04/09/2023 |
Cancelled 31/03/2025 |
| Lise Z5 – H56 LD II
82533950029 |
Lysis solution |
I |
ZYBIO INC. |
04/09/2023 |
Valid |
| Tira de Urinálise 14I
82533950028 |
Urine test strip |
II |
ZYBIO INC. |
28/08/2023 |
Valid |
| Lise Z5 – LD I
82533950027 |
Lysis solution |
I |
ZYBIO INC. |
28/08/2023 |
Valid |
| Lise Z5 – LB I
82533950026 |
Lysis solution |
I |
ZYBIO INC. |
28/08/2023 |
Valid |
| Diluente DN – Z5 I
82533950025 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
28/08/2023 |
Valid |
| Solução de Limpeza de Sonda I
82533950024 |
Not yet published |
I |
Not yet published |
28/08/2023 |
Cancelled 31/03/2025 |
| Fluido Focalizador I
82533950023 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
28/08/2023 |
Valid |
| Família Calibrador de Turbidez I
82533950022 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
21/08/2023 |
Valid |
| Família Controle de Turbidez I
82533950021 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
21/08/2023 |
Valid |
| Família Calibrador de Condutividade I
82533950020 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
21/08/2023 |
Valid |
| Controle de Condutividade I
82533950019 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
21/08/2023 |
Valid |
| Calibrador de Densidade
82533950018 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
21/08/2023 |
Valid |
| Controle de Densidade I
82533950017 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
24/07/2023 |
Valid |
| Controle de Cor I
82533950016 |
Solution for performance testing of equipment components |
I |
ZYBIO INC. |
24/07/2023 |
Valid |
| Sífilis
82533950015 |
Treponema pallidum total antibodies |
IV |
GUANGZHOU WONDFO BIOTECH CO. LTD |
15/05/2023 |
Until 15/05/2033 |
| HCV
82533950014 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
GUANGZHOU WONDFO BIOTECH CO. LTD |
17/04/2023 |
Until 17/04/2033 |
| SISTEMA DE ESPECTROMETRIA DE MASSA (MALDI-TOF)
82533950013 |
Microorganism identification or susceptibility testing instrument |
II |
ZYBIO INC. |
06/03/2023 |
Valid |
| Impressora Dry Imager
82533950012 |
Medical image printer |
I |
SHENZHEN KENID MEDICAL DEVICES CO., LTD |
13/02/2023 |
Valid |
| KIT DE PRÉ-TRATAMENTO DE AMOSTRA MALDI-TOF
82533950011 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
06/02/2023 |
Valid |
| Solução Matriz de Tratamento de Amostra – MALDI-TOF
82533950010 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
23/01/2023 |
Valid |
| KIT PRÉ TRATAMENTO DE AMOSTRA MICROBIOLÓGICA – MALDI-TOF
82533950009 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
23/01/2023 |
Valid |
| Kit de Pré Tratamento de Amostra de Hemocultura - MALDI TOF
82533950008 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
16/01/2023 |
Valid |
| Compressa de Gaze
82533950007 |
Gauze pads |
I |
KINGSTAR MEDICAL (XIANNING) CO., LTD. |
26/12/2022 |
Valid |
| Bolsa de Urina
82533950006 |
Collection bags |
I |
MEDIPLUS (INDIA) LIMITED
MEDIPLUS (INDIA) LIMITED (UNIT 2) |
05/12/2022 |
Valid |
| Swab Ponta Rayon
82533950005 |
Container or material for collection, storage or transport of biological samples |
I |
HANGZHOU GENESIS BIODETECTION AND BIOCONTROL CO., LTD. |
21/11/2022 |
Valid |
| Bolsa coletora de urina
82533950004 |
Collection bags |
I |
MEDIPLUS (INDIA) LIMITED |
27/10/2022 |
Valid |
| Lancetador Unishine
82533950002 |
Lancing device |
I |
TIANJIN HUAHONG TECHNOLOGY CO., LTD. |
15/09/2022 |
Valid |