30 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
ThEA SARS-CoV-2 plugin
Device
EU IVDD
·
Eu Ivd General
·RAM THz Solutions GmbH·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Rapid Test
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)
Device
EU IVDD
·
Eu Ivd General
·Genekam Biotechnology AG·On the market·32 countries
NanoRepro SARS-CoV-2 Antigen Rapid Test (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Rapid Test (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Schnelltest (5er Kit)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
NanoRepro SARS-CoV-2 Antigen Rapid Test(20 pcs Kit)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·August 2, 2023
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA Enforcement
Class II
·Ongoing·Abbott GmbH·April 10, 2024
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
FDA Enforcement
Class II
·Ongoing·Abbott GmbH·April 10, 2024
ThEA SARS-CoV-2 plugin
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·RAM THz Solutions GmbH·1 device
NanoRepro SARS-CoV-2 Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·1 device
NanoRepro SARS-CoV-2 Antigen Schnelltest (DE/EN)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·1 device