10,000 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

COVID-19 Antigen Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Hangzhou Clongene Biotech Co., Ltd.·1 device

RTPCR027

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Vircell, S.L·1 device

SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sejoy Biomedical Co., Ltd.·1 device

Strep A Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sejoy Biomedical Co., Ltd.·1 device

Chlamydia Pneumoniae IgA EIA

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device

HemosIL AcuStar Anti-Cardiolipin IgG Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

HemosIL AcuStar Anti-Cardiolipin IgM Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

Latex (K82)

Basic UDI-DI
EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

HemosIL AcuStar Anti-ß2 Glycoprotein-I IgG Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

BIOSYNEX AMPLIFLASH Malaria

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·BIOSYNEX·1 device

HemosIL AcuStar HIT Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

HemosIL CL Multi-Ab Controls

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory Company·1 device

CHORUS CLIA FECAL ELASTASE

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·1 device

Neonatal Phenylalanine Calibrators

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device

NeoMass CAH

Basic UDI-DI
EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device