Specialty Diagnostix GmbH

Importer

🇩🇪 Germany·1 Manufacturer

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

MedPath GmbH

Authorized representative

🇩🇪 Germany·537 Manufacturers·13464 Devices

Welch Allyn Limited

Importer

🇮🇪 Ireland·8 Manufacturers

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification

FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Next Generation Sequencing Based Tumor Profiling Test

FDA classification

FDA Class 2 ·Next Generation Sequencing Based Tumor Profiling Test

Tumor Gene Profiling Test

FDA classification

FDA Not Classified ·Tumor Gene Profiling Test

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Shanghai International Holding Corp. GmbH(Europe)

Authorized representative

🇩🇪 Germany·637 Manufacturers·33064 Devices