67 results · 46ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Met

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Infant Positioner, Rx, Use In Highly Monitored Setting

FDA classification
FDA Class 1 ·Infant Positioner, Rx, Use In Highly Monitored Setting

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Nucleic Acid Quantitation Kit

FDA classification
FDA Class 1 ·Nucleic Acid Quantitation Kit

Breast Milk Macronutrients Test System

FDA classification
FDA Class 2 ·Breast Milk Macronutrients Test System

Adjunctive Hemodynamic Indicator With Decision Point

FDA classification
FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

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

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

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

FDA classification
FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point For Military Use

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