10,000 results
·
53ms
·
Sources: EU EUDAMED, US FDA
Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit
Device
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·On the market
Leukemia mu-BCR Fusion Gene Real Time RT-PCR Kit
Device
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·On the market
Leukemia m-BCR Fusion Gene Real Time RT-PCR Kit
Device
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·On the market
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020659·IVD reagent kit containing 30 tests.
BCR-ABL1 p210 Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Zeesan Biotech Co., Ltd.·1 device
BCR-ABL1 p190 Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Zeesan Biotech Co., Ltd.·1 device
BCR-ABL1 Genotyping Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Zeesan Biotech Co., Ltd.·1 device
Amplidiag CarbaR+ MCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Mobidiag Ltd.·1 device
Laser BCR modification kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·7 devices
Cue COVID-19 Molecular Test
FDA 510(k)
FDA Class 2
·Microbiology
Cue COVID-19 Molecular Test
FDA 510(k)
FDA Class 2
·Microbiology
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FDA registration
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