111 results · 9ms · 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.

Ethyl Glucuronide (ETG) Rapid Test Kit (Urine)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

Ethyl Glucuronide (ETG) Rapid Test Kit (Urine)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

ETG Rapid Test Kit (Colloidal gold method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

Parathyroid hormone (CLIA)、Parathyroid hormone Calibrators

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

Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

One Step Ethyl Glucuronide (ETG) Test Kit (Urine)(Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

The ETG One Step Ethyl- β-D-Glucuronide Test (colloidal gold method)

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

Buffers (Unassignable ), Supplem. Reagents, etc

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·AusDiagnostics Pty Ltd·1 device

PlexPCR RespiVirus

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·3 devices

Step 2 Plates for Atypical Pneumonia 8-well

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Urinogenital (8-well)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Pneumonia (16-well)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Viral CSF (8-well)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Urinogenital and Resistance 12-well

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for STI (16-well)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Viral Panel 12-well

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Urinogenital and Resistance 12 well

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Sentosa SA C. diff PCR Test v2.0 (4x24)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BRAF V600 PCR Test (4x8)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device