Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

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

Burst Suppression Detection Software For Electroencephalograph

FDA classification

FDA Class 2 ·Burst Suppression Detection Software For Electroencephalograph

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Adamts13 Activity Test System

FDA classification

FDA Class 2 ·Adamts13 Activity Test System

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification

FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Anti-Factor Xa Activity Test System, Apixaban

FDA classification

FDA Class 2 ·Anti-Factor Xa Activity Test System, Apixaban

Image Processing Device For Estimation Of External Blood Loss

FDA classification

FDA Class 2 ·Image Processing Device For Estimation Of External Blood Loss

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Clip, Implantable, Reprocessed

FDA classification

FDA Class 2 ·Clip, Implantable, Reprocessed

Acute Kidney Injury Test System

FDA classification

FDA Class 2 ·Acute Kidney Injury Test System

Diabetes Digital Therapeutic Device

FDA classification

FDA Class 2 ·Diabetes Digital Therapeutic Device

Flow Cytometric Test System For Hematopoietic Neoplasms

FDA classification

FDA Class 2 ·Flow Cytometric Test System For Hematopoietic Neoplasms

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

FDA classification

FDA Class 2 ·Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Prognostic Test For Development Or Progression Of Preeclampsia

FDA classification

FDA Class 2 ·Prognostic Test For Development Or Progression Of Preeclampsia

Zika Virus Serological Reagents

FDA classification

FDA Class 2 ·Zika Virus Serological Reagents

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens