58 results · 48ms · Sources: EU EUDAMED, US FDA

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification
FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification
FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Whole Exome Sequencing Constituent Device

FDA classification
FDA Class 2 ·Whole Exome Sequencing Constituent Device

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Test, Volatile Organic Compounds Breath Analysis

FDA classification
Test, Volatile Organic Compounds Breath Analysis

Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

Test, Opiates, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Opiates, Employment And Insurance Testing, Exempt

Test, Codeine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Codeine, Employment And Insurance Testing, Exempt

Test, Methaqualone, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Methaqualone, Employment And Insurance Testing, Exempt

Test, Amphetamine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Amphetamine, Employment And Insurance Testing, Exempt

Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Test, Cannabinoid, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Cannabinoid, Employment And Insurance Testing, Exempt

Test, Benzodiazepine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Benzodiazepine, Employment And Insurance Testing, Exempt

Test, Propoxyphene, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Propoxyphene, Employment And Insurance Testing, Exempt

Test, Barbiturate, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Barbiturate, Employment And Insurance Testing, Exempt

Test, Methamphetamine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Methamphetamine, Employment And Insurance Testing, Exempt

Test, Morphine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Morphine, Employment And Insurance Testing, Exempt