940 results · 21ms · Sources: EU EUDAMED, US FDA

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification
FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification
FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Infliximab Test System

FDA classification
FDA Class 2 ·Infliximab Test System

Gabapentin Assay

FDA classification
FDA Class 2 ·Gabapentin Assay

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Chromogranin A

FDA classification
FDA Class 2 ·Chromogranin A

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

FDA classification
FDA Class 2 ·Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

FDA classification
FDA Class 2 ·Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Tryptase Assay System

FDA classification
FDA Class 2 ·Tryptase Assay System

Autoantibodies, Nuclear Body Protein, Sp100

FDA classification
FDA Class 2 ·Autoantibodies, Nuclear Body Protein, Sp100

Autoantibodies, Nuclear Pore Glycoprotein Gp210

FDA classification
FDA Class 2 ·Autoantibodies, Nuclear Pore Glycoprotein Gp210

External Upper Limb Tremor Stimulator

FDA classification
FDA Class 2 ·External Upper Limb Tremor Stimulator

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

FDA classification
FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Brain Intraparenchymal Infusion Cannula

FDA classification
FDA Class 2 ·Brain Intraparenchymal Infusion Cannula

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

FDA classification
FDA Class 2 ·System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification
FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification
FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification
FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test