21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Magnetic Compression Anastomosis System

FDA classification

FDA Class 2 ·Magnetic Compression Anastomosis System

Conformal Brachytherapy Source

FDA classification

FDA Class 2 ·Conformal Brachytherapy Source

Surgical Film

FDA classification

FDA Class 2 ·Surgical Film

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Microbial Colony Image Assessment System

FDA classification

FDA Class 2 ·Microbial Colony Image Assessment System

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification

FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

FDA classification

FDA Class 2 ·X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Complete Gene Expression Profiling Accessory Reagents

FDA classification

FDA Class 2 ·Complete Gene Expression Profiling Accessory Reagents

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

FDA classification

FDA Class 2 ·Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

FDA classification

FDA Class 2 ·Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Antigen, Invasive Fungal Pathogens

FDA classification

FDA Class 2 ·Antigen, Invasive Fungal Pathogens

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA classification

FDA Class 2 ·Plate, Bone, Growth Control, Pediatric, Epiphysiodesis