| Família VB12 Chemiluminescent Binding Assay Kit
82444370234 |
Vitamin B12 |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Família Thyroid Autoantibodies Control
82444370233 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Total T3 Chemiluminescent Immunoassay Kit
82444370232 |
Triiodothyronine (T3) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Pad Ezi
82444370231 |
Not yet published |
I |
Not yet published |
28/04/2025 |
Cancelled 17/08/2026 |
| Hepatitis B surface antigen (HBsAg) Test Kit (Colloidal Gold)
82444370230 |
Hepatitis B surface antigen (HBsAg) |
IV |
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. |
28/04/2025 |
Until 28/04/2035 |
| Família Hypertension Marker Control
82444370229 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Progesterone Chemiluminescent Immunoassay Kit
82444370228 |
Progesterone |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| LH Chemiluminescent Immunoassay Kit
82444370227 |
Luteinizing hormone (LH) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Insulin Chemiluminescent Immunoassay Kit
82444370226 |
Insulin |
II |
MACCURA BIOTECHNOLOGY CO LTD |
28/04/2025 |
Valid |
| Human Papillomavirus (23 types) Genotyping Kit (Melt-Fluorescence PCR)
82444370225 |
Human papillomavirus (HPV) |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
22/04/2025 |
Until 22/04/2035 |
| D-Dimer Quantitative Test Kit (Time-Resolved FIA)
82444370224 |
D-dimer |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
07/04/2025 |
Until 07/04/2035 |
| CRP Quantitative Test Kit (Time-Resolved FIA)
82444370223 |
High-sensitivity C-reactive protein (hs-CRP) |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
07/04/2025 |
Valid |
| Família Folate Chemiluminescent Binding Assay Kit
82444370222 |
Folate |
II |
MACCURA BIOTECHNOLOGY CO LTD |
07/04/2025 |
Valid |
| Família Growth and Glucose Metabolism Control
82444370221 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
07/04/2025 |
Valid |
| Free T3 Chemiluminescent Immunoassay Kit
82444370220 |
Free triiodothyronine (FT3) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
07/04/2025 |
Valid |
| Free T4 Chemiluminescent Immunoassay Kit
82444370219 |
Free thyroxine (FT4) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
07/04/2025 |
Valid |
| FSH Chemiluminescent Immunoassay Kit
82444370218 |
Follicle-stimulating hormone (FSH) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
07/04/2025 |
Valid |
| cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)
82444370217 |
Combined parameters in one product - class III |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
31/03/2025 |
Until 31/03/2035 |
| NT-proBNP Quantitative Test Kit (Time-Resolved FIA)
82444370216 |
Human brain natriuretic peptide (BNP) |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
31/03/2025 |
Until 31/03/2035 |
| Ferritin Chemiluminescent Immunoassay Kit
82444370215 |
Ferritin |
II |
MACCURA BIOTECHNOLOGY CO LTD |
17/03/2025 |
Valid |
| Estradiol Chemiluminescent Immunoassay Kit
82444370214 |
Estradiol |
II |
MACCURA BIOTECHNOLOGY CO LTD |
17/03/2025 |
Valid |
| Cortisol Chemiluminescent Immunoassay Kit
82444370213 |
Cortisol/cortisone |
II |
MACCURA BIOTECHNOLOGY CO LTD |
17/03/2025 |
Valid |
| Anti-Thyroid Peroxidase Antibody Chemiluminescent Immunoassay Kit
82444370212 |
Thyroid peroxidase (TPO) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
05/03/2025 |
Valid |
| Thyroglobulin Antibody Chemiluminescent Immunoassay Kit
82444370211 |
Thyroglobulin (Tg) |
II |
MACCURA BIOTECHNOLOGY CO LTD |
05/03/2025 |
Valid |
| Família Anemia Markers Control
82444370210 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
05/03/2025 |
Valid |
| Família Chemiluminescence Immunoassay Multi-analytes (CIM) Control
82444370209 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
05/03/2025 |
Valid |
| Analisador Automático de Hematologia D7-CRP
82444370208 |
Cell and platelet analyzer or counter |
II |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
05/03/2025 |
Valid |
| Analisador Automático de Hematologia DH-800[T7]CS
82444370207 |
Cell and platelet analyzer or counter |
II |
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD |
05/03/2025 |
Valid |
| Família Analisadores Automáticos de Quimioluminescência
82444370206 |
Immunoassay instrument |
II |
MACCURA MEDICAL INSTRUMENT CO., LTD. |
05/03/2025 |
Valid |
| FAMÍLIA DIAZYME CALPROTECTIN ASSAY
82444370205 |
Calprotectin |
II |
DIAZYME LABORATORIES, INC. |
05/03/2025 |
Valid |
| Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370204 |
Treponema pallidum total antibodies |
IV |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
24/02/2025 |
Until 24/02/2035 |
| Dengue NS1 & IgG/IgM Combo Test Kit
82444370203 |
Dengue |
III |
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. |
24/02/2025 |
Until 24/02/2035 |
| HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370202 |
Hepatitis B surface antigen (HBsAg) |
IV |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
24/02/2025 |
Until 24/02/2035 |
| HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)
82444370201 |
HIV-1/HIV-2 antigen/antibody |
IV |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
24/02/2025 |
Until 24/02/2035 |
| OG-P960 Real-time PCR system
82444370200 |
Nucleic acid analyzer |
II |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
17/02/2025 |
Valid |
| Fully Automatic Digital Feces Analyzer FA280
82444370199 |
Stool analyzer |
II |
SICHUAN ORIENTER BIOTECHNOLOGY CO., LTD. |
17/02/2025 |
Valid |
| Fecal Occult Blood Rapid Test Cassette (Feces)
82444370198 |
Fecal occult blood |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
17/02/2025 |
Until 17/02/2035 |
| TP Syphilis Antibody Test Kit
82444370197 |
Treponema pallidum total antibodies |
IV |
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. |
17/02/2025 |
Until 17/02/2035 |
| COVID-19 (SARS-CoV-2) Antigen Self-Test Kit
82444370196 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. |
17/02/2025 |
Until 17/02/2035 |
| Sample Diluent
82444370195 |
Buffers, diluents and other solutions for laboratory analysis |
I |
SICHUAN ORIENTER BIOTECHNOLOGY CO., LTD. |
17/02/2025 |
Valid |
| Sample Collection Tube
82444370194 |
Container or material for collection, storage or transport of biological samples |
I |
SICHUAN ORIENTER BIOTECHNOLOGY CO., LTD. |
17/02/2025 |
Valid |
| Group A Rotavirus & Adenovirus Antigen Test Kit (Colloidal Gold)
82444370193 |
Combined parameters in one product - class II |
II |
SICHUAN ORIENTER BIOTECHNOLOGY CO., LTD. |
17/02/2025 |
Valid |
| cTnI Quantitative Test Kit (Time-Resolved FIA)
82444370192 |
Troponin |
III |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
10/02/2025 |
Until 10/02/2035 |
| HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) (Cassette)
82444370191 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
10/02/2025 |
Until 10/02/2035 |
| Disposable Virus Sampling Tube
82444370190 |
Container or material for collection, storage or transport of biological samples |
I |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
27/01/2025 |
Valid |
| OG-N32 Nucleic Acid Purification System
82444370189 |
Sample preparation and processing instrument - pre-analytical phase |
I |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
27/01/2025 |
Valid |
| Disposable Cervical Sampling Kit
82444370188 |
Container or material for collection, storage or transport of biological samples |
I |
ZHEJIANG ORIENT GENE BIOTECH CO., LTD. |
27/01/2025 |
Valid |
| Família Hematology Analyzer Control
82444370187 |
Blood cell count |
II |
MACCURA BIOTECHNOLOGY CO LTD |
27/01/2025 |
Valid |
| Família Hematology Analyzer Reticulocyte Control
82444370186 |
Blood cell count |
II |
MACCURA BIOTECHNOLOGY CO LTD |
27/01/2025 |
Valid |
| Família Hematology Analyzer Fluorescent Platelets Control
82444370185 |
Blood cell count |
II |
MACCURA BIOTECHNOLOGY CO LTD |
27/01/2025 |
Valid |