| ANApro
80464810747 |
Antinuclear antibody (ANA) |
II |
GENERIC ASSAYS GA |
17/12/2020 |
Valid |
| ANAscreen
80464810746 |
Antinuclear antibody (ANA) |
II |
GENERIC ASSAYS GA |
17/12/2020 |
Valid |
| FungiXpert Candida Mannan IgM Antibody Detection K-Set (Lateral Flow Assay)
80464810745 |
Candida spp. |
II |
GENOBIO PHARMACEUTICAL CO., LTD |
10/12/2020 |
Valid |
| FungiXpert Candida Mannan IgG Antibody Detection K-Set (Lateral Flow Assay)
80464810744 |
Candida spp. |
II |
GENOBIO PHARMACEUTICAL CO., LTD |
10/12/2020 |
Valid |
| FungiXpert Candida Mannan Detection K-Set (Lateral Flow Assay)
80464810743 |
Candida spp. |
II |
GENOBIO PHARMACEUTICAL CO., LTD |
10/12/2020 |
Valid |
| FungiXpert Aspergillus IgM Antibody Detection K-Set (Lateral Flow Assay)
80464810742 |
Aspergillus spp. |
II |
GENOBIO PHARMACEUTICAL |
10/12/2020 |
Valid |
| FungiXpertÒ Aspergillus IgG Antibody Detection K-Set (Lateral Flow Assay)
80464810741 |
Aspergillus spp. |
II |
GENOBIO PHARMACEUTICAL CO., LTD |
10/12/2020 |
Valid |
| FungiXpert Aspergillus Galactomannan Detection K-Set (Lateral Flow Assay)
80464810740 |
Aspergillus spp. |
II |
GENOBIO PHARMACEUTICAL CO., LTD |
10/12/2020 |
Valid |
| GLUTEN’ALARM®
80464810739 |
Celiac disease antibody |
II |
VEDALAB |
10/12/2020 |
Valid |
| NT-PROBNP-CHECK-1
80464810738 |
Not yet published |
II |
Not yet published |
10/12/2020 |
Cancelled 09/06/2025 |
| QUICKPROFILE Saliva Drugs of Abuse test
80464810737 |
Drugs of abuse panel |
II |
LUMIQUICK DIAGNOSTICS, INC. |
26/11/2020 |
Valid |
| Interleukin-10 human ELISA
80464810736 |
Interleukins |
II |
DEMEDITEC |
26/11/2020 |
Valid |
| Família FloMass Drugs of abuse in urine
80464810735 |
Drugs of abuse panel |
II |
B.S.N. BIOLOGICAL SALES NETWORK S.R.L. |
26/11/2020 |
Valid |
| Família FloMass Antibiotics in Serum
80464810734 |
Combined parameters in one product - class II |
II |
B.S.N. BIOLOGICAL SALES NETWORK S.R.L. |
26/11/2020 |
Valid |
| FAMÍLIA FRUCTOSAMINE
80464810733 |
Fructosamine |
II |
BEN S.R.L - BIOCHEMICAL ENTERPRISE |
19/11/2020 |
Valid |
| HOMOCYSTEINE (Hcy) em família
80464810732 |
Homocysteine |
II |
LTA |
26/11/2020 |
Valid |
| Melatonin ELISA
80464810731 |
Not yet published |
II |
Not yet published |
12/11/2020 |
Cancelled 08/03/2021 |
| pANCA IFA plus
80464810730 |
Not yet published |
II |
Not yet published |
12/11/2020 |
Cancelled 08/03/2021 |
| cANCA IFA plus
80464810729 |
Not yet published |
II |
Not yet published |
12/11/2020 |
Cancelled 08/03/2021 |
| nDNA IFA plus
80464810728 |
Not yet published |
II |
Not yet published |
12/11/2020 |
Cancelled 08/03/2021 |
| Família Glycomark
80464810727 |
1,5-Anhydroglucitol |
II |
NIPPON KAYAKU CO., LTD. TAKASAKI PLANT |
12/11/2020 |
Valid |
| IDK® Bile Acids
80464810726 |
Bile acids |
II |
IMMUNDIAGNOSTIK |
05/11/2020 |
Valid |
| Medizym® anti-IA2 M
80464810725 |
Anti-pancreatic islet cell antibody |
II |
MEDIPAN |
05/11/2020 |
Valid |
| IDK® Serotonin ELISA
80464810724 |
Serotonin |
II |
IMMUNDIAGNOSTIK |
05/11/2020 |
Valid |
| Medizym® anti-GAD M
80464810723 |
Anti-glutamic acid decarboxylase (GAD) antibody |
II |
MEDIPAN |
29/10/2020 |
Valid |
| MiraVista Histoplasma Urine Antigen LFA
80464810722 |
Not yet published |
II |
Not yet published |
29/10/2020 |
Cancelled 06/06/2022 |
| MutaPLEX® EU/BAC/BIF
80464810721 |
Combined parameters in one product - class II |
II |
IMMUNDIAGNOSTIK |
29/10/2020 |
Valid |
| AMH ELISA
80464810720 |
Anti-Müllerian hormone (AMH) |
II |
DEMEDITEC |
29/10/2020 |
Valid |
| MutaPLEX® AKM/FAEP
80464810719 |
Combined parameters in one product - class II |
II |
IMMUNDIAGNOSTIK |
22/10/2020 |
Valid |
| MutaPLEX® PRE/RU/LA
80464810718 |
Not yet published |
II |
Not yet published |
22/10/2020 |
Cancelled 09/06/2025 |
| DHEA-S ELISA
80464810717 |
Dehydroepiandrosterone sulfate (DHEA-S) |
II |
LABOR DIAGNOSTIKA NORD |
15/10/2020 |
Valid |
| Melatonin Direct Saliva ELISA
80464810716 |
Melatonin |
II |
LABOR DIAGNOSTIKA NORD |
15/10/2020 |
Valid |
| Cholesterol Health Care Test
80464810715 |
Total cholesterol |
II |
CARE DIAGNOSTICA |
08/10/2020 |
Valid |
| Blood Glucose Health Care Test
80464810714 |
Glucose |
II |
CARE DIAGNOSTICA |
08/10/2020 |
Valid |
| sdLDL em família
80464810713 |
Low-density lipoprotein (LDL) |
II |
DIAZYME LABORATORIES |
08/10/2020 |
Valid |
| Food-specific IgG antibodies test kit
80464810712 |
Systems, discs and strips for specific anti-IgE (allergens), single or grouped - food screening panels |
II |
HANGZHOU ZHEDA DIXUN BIOLOGICAL GENE ENGINEERING CO., LTD. |
01/10/2020 |
Valid |
| Food-specific IgG4 antibodies test kit
80464810711 |
Systems, discs and strips for specific anti-IgE (allergens), single or grouped - food screening panels |
II |
HANGZHOU ZHEDA DIXUN BIOLOGICAL GENE ENGINEERING CO., LTD. |
01/10/2020 |
Valid |
| Lactoferrin ELISA
80464810710 |
Lactoferrin |
II |
IMMUNDIAGNOSTIK AG |
24/09/2020 |
Valid |
| Família BILE ACIDS
80464810709 |
Bile acids |
II |
BEN BIOCHEMICAL ENTERPRISE SRL |
21/09/2020 |
Valid |
| ClinCal® - Calibrator Plasma Calibrator lyophilised FOR AMINO ACIDS (by Amino Acid Analyser (AAA))
80464810708 |
Amino acids |
II |
RECIPE |
21/09/2020 |
Valid |
| Stool Preparation System - SAS
80464810707 |
Container or material for collection, storage or transport of biological samples |
I |
IMMUNDIAGNOSTIK |
10/09/2020 |
Valid |
| QuickProfile™ Zika Virus IgG/IgM Combo Test
80464810706 |
Zika virus IgM/IgG |
IV |
LUMIQUICK DIAGNOSTICS, INC. |
08/09/2020 |
Until 08/09/2030 |
| Família Multipurpose Viral Sampling System
80464810705 |
Container or material for collection, storage or transport of biological samples |
I |
ZHUHAI ENCODE MEDICAL ENGINEERING CO.,LTD |
20/08/2020 |
Valid |
| AkironNEO
80464810704 |
Immunoassay instrument |
II |
MEDIPAN |
17/08/2020 |
Valid |
| H. pylori Saliva Test
80464810703 |
Helicobacter pylori |
II |
SAVYON DIAGNOSTICS LTD |
10/08/2020 |
Valid |
| THUNDERBOLT
80464810702 |
Immunoassay instrument |
II |
GOLD STANDARDS DIAGNOSTICS |
27/07/2020 |
Valid |
| QuickProfile™ COVID-19 Antigen Test
80464810701 |
Coronavirus |
III |
LUMIQUICK DIAGNOSTICS, INC |
09/07/2020 |
Until 09/07/2030 |
| QuickProfile™ Influenza A+B Test CARD (FLU A+B)
80464810700 |
Influenza A and B viruses |
III |
LUMIQUICK DIAGNOSTICS, INC. |
13/07/2020 |
Until 13/07/2030 |
| GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR
80464810699 |
Coronavirus |
III |
NOVATEC IMMUNDIAGNOSTICA GMBH |
29/06/2020 |
Until 29/06/2030 |
| Quicknostics® COVID-19 RT PCR
80464810698 |
Coronavirus |
III |
LUMIQUICK DIAGNOSTICS, INC. |
29/06/2020 |
Until 29/06/2030 |