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

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

FDA classification

FDA Class 2 ·Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Serpina1 Variant Detection System

FDA classification

FDA Class 2 ·Serpina1 Variant Detection System

21-Hydroxylase Antibody (21-Ohab)

FDA classification

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

Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

FDA classification

FDA Unclassified ·Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

FDA classification

FDA Unclassified ·Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA classification

FDA Class 2 ·Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

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

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

FDA classification

FDA Class 2 ·Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Parainfluenza Multiplex Nucleic Acid Assay

FDA classification

FDA Class 2 ·Parainfluenza Multiplex Nucleic Acid Assay

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

Influenza A And Influenza B Multiplex Nucleic Acid Assay

FDA classification

FDA Class 2 ·Influenza A And Influenza B Multiplex Nucleic Acid Assay

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-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

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification

FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

FDA classification

FDA Class 2 ·Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

Plasmodium Spp. Detection Reagents

FDA classification

FDA Class 2 ·Plasmodium Spp. Detection Reagents

Immunoassay, Anti-Seizure Drug

FDA classification

FDA Class 2 ·Immunoassay, Anti-Seizure Drug