16 results · 17ms · Sources: EU EUDAMED, US FDA

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

ATK HPV

Device
EU IVDR · Eu Ivd Class C ·Arghavan Teb Kavian·On the market·3 countries

GONOCOCCAL ANTIGEN DETECTION

Device
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

Device
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

Chlamydia Antigen Rapid Test Kit

Device
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·3 countries

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Cytocell Limited·2 devices

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Device
EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·On the market·11 countries

HPV High Risk Real Time PCR Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Arghavan Teb Kavian·1 device

Gonorrhea Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Chlamydia and Gonorrhea Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Chlamydia Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device