System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

FDA classification

FDA Class 2 ·Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

FDA classification

FDA Class 2 ·Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

FDA classification

FDA Class 2 ·Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

FDA classification

FDA Class 2 ·Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA classification

FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

FDA classification

FDA Class 1 ·Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification

FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification

FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

FDA classification

FDA Not Classified ·Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

FDA classification

FDA Class 2 ·Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

FDA classification

FDA Class 1 ·Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

FDA classification

FDA Class 2 ·Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

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