161 results
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9ms
·
Sources: EU EUDAMED, US FDA
Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Sansure Biotech Inc.·1 device
Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Sansure Biotech Inc.·1 device
Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Sansure Biotech Inc.·1 device
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Sansure Biotech Inc.·1 device
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Sansure Biotech Inc.·2 devices
CHORUS HELICOBACTER PYLORI IgA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
CHORUS HELICOBACTER PYLORI IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
CHORUS MYCOPLASMA PNEUMONIAE IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
CHORUS MYCOPLASMA PNEUMONIAE IgA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
CHORUS HERPES SIMPLEX 1+2 IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
HbA1c
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory SpA·1 device
CHORUS HERPES SIMPLEX 1 IgG RECOMBINANT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·1 device
CHORUS CHIKUNGUNYA IgM
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·DIESSE Diagnostica Senese S.p.A·1 device
URIC ACID T FL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Chema Diagnostica Srl·3 devices
HPV Genotyping Kit (18 Types)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Guangzhou KingCreate Biotechnology Co., Ltd.·1 device
MosaiQ® AiPlex CTDplus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·AliveDx Suisse SA·2 devices
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices
Upright microscope
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Euromex microscopen bv·1 device
Total IgE (CLIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Maccura Biotechnology Co., Ltd. ·4 devices
iFlash-Total β HCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices