1,891 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdd
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Phenylalanine (PKU) neonatal Screening Assay
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·On the market·32 countries
Phenylalanine (PKU) neonatal Screening Assay
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·IBL International GmbH·On the market·32 countries
BCR-ABL p190 digital PCR detection kit
Device
EU IVDD
·
Eu Ivd General
·TargetingOne Technology (Beijing) Corporation·On the market
BCR-ABL p210 digital PCR detection kit
Device
EU IVDD
·
Eu Ivd General
·TargetingOne Technology (Beijing) Corporation·On the market
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit
Device
EU IVDD
·
Eu Ivd General
·SHANGHAI ZJ BIO-TECH CO., LTD·On the market
Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)
Device
EU IVDD
·
Eu Ivd General
·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
23andMe Personal Genome Service
Device
EU IVDD
·
Eu Ivd General
·23andMe, Inc.·On the market·5 countries
23andMe Personal Genome Service
Device
EU IVDD
·
Eu Ivd General
·23andMe, Inc.·No longer on the market·5 countries
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market