26 results · 17ms · 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.

Carcinoembryonic Antigen (CLIA)、CEA Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

Carcinoembryonic Antigen(CEA)Assay Kit (Chemiluminescent Microparticle Immunoassay)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·URIT Medical Electronic Co.,Ltd.·1 device

Autof ms1000

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·7 countries

Autof ms2600

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·32 countries

Autof ms1600

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·32 countries

Autof ms800

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·32 countries

Autof ms600

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·32 countries

Autof ms2000

Device
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·On the market·32 countries

STREP. B DETECTION BY NA REAGENTS

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·No longer on the market·1 country

STREP. B DETECTION BY NA REAGENTS

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·No longer on the market

Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·On the market·1 country

Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·On the market·1 country

MYCOBACTERIAL DETECTION BY NA REAGENTS

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·On the market·1 country

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·On the market·1 country

Automated Mass Spectrometry Microbial Identification System

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·1 device

Automated Mass Spectrometry Microbial Identification System

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·1 device

Automated Mass Spectrometry Microbial Identification System

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·1 device

Automated Mass Spectrometry Microbial Identification System

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·1 device

Automated Mass Spectrometry Microbial Identification System

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Labtec Instruments Co.,Ltd.·1 device