High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

FDA classification

FDA Class 2 ·High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

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

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

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

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

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

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

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