BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·VISTA LORDOTIC INTERBODY FUSION CAGE

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

REVEEL ENDOSCOPIC RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

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

Microfilter, Blood Transfusion

FDA classification

FDA Class 2 ·Microfilter, Blood Transfusion

Complement C1q, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C1q, Antigen, Antiserum, Control

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

FDA classification

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

Sensor, Pressure, Aneurysm, Implantable

FDA classification

FDA Class 2 ·Sensor, Pressure, Aneurysm, Implantable

Over-The-Counter Covid-19 Antigen Test

FDA classification

FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay