2,427 results · 38ms · Sources: EU EUDAMED, US FDA

Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

FDA classification
Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

FDA classification
FDA Class 2 ·System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

FDA classification
FDA Class 2 ·Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

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

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification
FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

FDA classification
FDA Not Classified ·Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

FDA classification
FDA Class 1 ·Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Nitric Oxide Generator And Delivery System

FDA classification
FDA Class 3 ·Nitric Oxide Generator And Delivery System

Ataxiagraph With Interpretive Software

FDA classification
FDA Class 1 ·Ataxiagraph With Interpretive Software

Gastric Emptying Breath Test

FDA classification
FDA Class 3 ·Gastric Emptying Breath Test

Ultrasound, Skin Permeation

FDA classification
FDA Class 2 ·Ultrasound, Skin Permeation

Dorsal Root Ganglion Stimulator For Pain Relief

FDA classification
FDA Class 3 ·Dorsal Root Ganglion Stimulator For Pain Relief

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification
FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Peripheral Blood Processing Device For Osteoarthritis

FDA classification
FDA Not Classified ·Peripheral Blood Processing Device For Osteoarthritis

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

FDA classification
FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

FDA classification
FDA Class 2 ·Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification
FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

Reagents For Molecular Diagnostic Test Systems

FDA classification
FDA Class 1 ·Reagents For Molecular Diagnostic Test Systems