| Rubella IgG Antibody Chemiluminescent Immunoassay Kit
82444370284 |
Rubella virus |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CMV IgM Antibody Chemiluminescent Immunoassay Kit
82444370283 |
Cytomegalovirus (CMV) IgM |
IV |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| Família Tumor Marker Control
82444370282 |
Combined parameters in one product - class III |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CEA Chemiluminescent Immunoassay Kit
82444370281 |
Carcinoembryonic antigen (CEA) |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| Rubella IgM Antibody Chemiluminescent Immunoassay Kit
82444370280 |
Rubella virus |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CMV IgG Antibody Chemiluminescent Immunoassay Kit
82444370279 |
Cytomegalovirus (CMV) IgG |
IV |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CA 125 Chemiluminescent Immunoassay Kit
82444370278 |
CA 125 antigen |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CA 19-9 Chemiluminescent Immunoassay Kit
82444370277 |
CA 19-9 antigen |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| CA 15-3 Chemiluminescent Immunoassay Kit
82444370276 |
CA 15-3 antigen |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| AFP Chemiluminescent Immunoassay Kit
82444370275 |
Alpha-fetoprotein (AFP) |
III |
MACCURA BIOTECHNOLOGY CO LTD |
13/10/2025 |
Until 13/10/2035 |
| Autoteste Rápido para Covid-19 (Antígeno)
82444370274 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
29/09/2025 |
Until 29/09/2035 |
| Mpox Virus Detection Kit (Fluorescence PCR)
82444370273 |
Orthopoxvirus |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
15/09/2025 |
Until 15/09/2035 |
| Família Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)
82444370272 |
Vitamin B12 |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
15/09/2025 |
Valid |
| Família AMH Quantitative Test Kit (Time-Resolved FIA)
82444370271 |
Anti-Müllerian hormone (AMH) |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família Folic Acid (FA) Quantitative Test Kit (Time-Resolved FIA)
82444370270 |
Vitamin B12 |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família Cortisol Quantitative Test Kit (Time-Resolved FIA)
82444370269 |
Cortisol/cortisone |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família Ferritin Quantitative Test Kit (Time-Resolved FIA)
82444370268 |
Ferritin |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família FSH Quantitative Test Kit (Time-Resolved FIA)
82444370267 |
Follicle-stimulating hormone (FSH) |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família TES Quantitative Test Kit (Time-Resolved FIA)
82444370266 |
Testosterone |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família Estradiol Quantitative Test Kit (Time-Resolved FIA)
82444370265 |
Estradiol |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família PROG Quantitative Test Kit (Time-Resolved FIA)
82444370264 |
Progesterone |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família PRL Quantitative Test Kit (Time-Resolved FIA)
82444370263 |
Prolactin |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
08/09/2025 |
Valid |
| Família RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)
82444370262 |
Combined parameters in one product - class II |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
01/09/2025 |
Valid |
| Família RSV Antigen Fluorescent Rapid Test Cassette (Swab)
82444370261 |
Respiratory syncytial virus (RSV) |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
01/09/2025 |
Valid |
| Família Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)
82444370260 |
Adenovirus |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
01/09/2025 |
Valid |
| Família Estação de Trabalho Automática para Análise Hematológica LABAS F 9000 X
82444370259 |
Sample preparation and processing instrument - pre-analytical phase |
I |
MACCURA MEDICAL INSTRUMENT CO., LTD. |
01/09/2025 |
Valid |
| Família IL-6 Quantitative Test Kit (Time-Resolved FIA)
82444370258 |
Interleukins |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
01/09/2025 |
Valid |
| Família LH Quantitative Test Kit (Time-Resolved FIA)
82444370257 |
Luteinizing hormone (LH) |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
01/09/2025 |
Valid |
| Família Sistema de Automação de Fluxo de Trabalho para Análise Hematológica LABAS F 2000
82444370256 |
Sample preparation and processing instrument - pre-analytical phase |
I |
MACCURA MEDICAL INSTRUMENT CO., LTD. |
01/09/2025 |
Valid |
| Kit Rápido de Detecção de Antígeno de SARS-CoV-2 (COVID-19)
82444370255 |
Coronavirus |
III |
JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. |
01/09/2025 |
Until 01/09/2035 |
| Família Diazyme Adenosine Deaminase Assay Kit
82444370254 |
Adenosine deaminase (ADA) |
II |
DIAZYME LABORATORIES, INC. |
18/08/2025 |
Valid |
| Kit de Reagentes para Analisador de Hematologia PTD-103
82444370253 |
Buffers, diluents and other solutions for laboratory analysis |
I |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
30/06/2025 |
Valid |
| Família Analisadores Automáticos de Hematologia Imunológica
82444370252 |
Cell and platelet analyzer or counter |
II |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
30/06/2025 |
Valid |
| eyePlate
82444370251 |
Ophthalmic implant |
III |
RHEON MEDICAL SA |
30/06/2025 |
Until 30/06/2035 |
| Reagente de Proteína C Reativa PF02 (Imunocromatografia por Fluorescência)
82444370250 |
C-reactive protein (CRP) |
II |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
16/06/2025 |
Valid |
| Sample Diluent No.3
82444370249 |
Buffers, diluents and other solutions for laboratory analysis |
I |
MACCURA BIOTECHNOLOGY CO LTD |
16/06/2025 |
Valid |
| Família Thyroid Function Control
82444370248 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
16/06/2025 |
Valid |
| Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
82444370247 |
Combined parameters - respiratory panel |
III |
HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY |
09/06/2025 |
Until 09/06/2035 |
| miLab™ Platform
82444370246 |
Sample preparation and processing instrument - pre-analytical phase |
I |
NOUL CO., LTD. |
02/06/2025 |
Valid |
| 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 |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
26/05/2025 |
Until 26/05/2035 |
| Família Sistema Automático de Processamento de Amostras DH-6000
82444370244 |
Sample preparation and processing instrument - pre-analytical phase |
I |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
26/05/2025 |
Valid |
| Família Sistema Automático de Processamento de Amostras DH-8000
82444370243 |
Sample preparation and processing instrument - pre-analytical phase |
I |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
26/05/2025 |
Valid |
| miLab™ Cartridge BCM
82444370242 |
Blood cell count |
II |
NOUL CO., LTD. |
19/05/2025 |
Valid |
| SafeFix™
82444370241 |
Buffers, diluents and other solutions for laboratory analysis |
I |
NOUL CO., LTD. |
12/05/2025 |
Valid |
| Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370240 |
Dengue |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
28/04/2025 |
Until 28/04/2035 |
| ß-HCG Chemiluminescent Immunoassay Kit
82444370239 |
Beta human chorionic gonadotropin (beta-hCG) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Família Hormones Control
82444370238 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Total T4 Chemiluminescent Immunoassay Kit
82444370237 |
Thyroxine (T4) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| TSH Chemiluminescent Immunoassay Kit
82444370236 |
Thyroid-stimulating hormone (TSH) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Testosterone Chemiluminescent Immunoassay Kit
82444370235 |
Testosterone |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |