43 results · 18ms · 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.

Napsin A (QR058)

Device
EU IVDD · Eu Ivd General ·biocyc Biotechnologie GmbH & Co. KG·On the market

CoxA16 & EV71 Real Time PCR Kit

Device
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·On the market·32 countries

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

Device
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

Device
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)

Device
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Monkeypox Virus Antigen Detection Kit (Immunochromatography)

Device
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Monkeypox Virus Antigen Detection Kit (Immunochromatography)

Device
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market

Cervical Pre-cancer And Cancer Rapid Test Kit (Colloidal gold method)

Device
EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device
EU IVDD · Eu Ivd General ·Gold Probe Diagnostic Biotechnology Inc. MF·On the market

BioCLIA Autoimmune Reagent Kit, Nucleosome

Device
EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

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

ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

MLH1 Gene Methlyation Detection Kit Multiplex Fluorescence Polymerase Chain Reaction

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

EGFR Gene T790M Mutation Detection Kit (Digital PCR)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries

Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)

Device
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·On the market·32 countries