Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

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

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

FDA classification

FDA Class 2 ·System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Non-Stainless Steel Needle

FDA classification

FDA Class 2 ·Non-Stainless Steel Needle

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Brain Intraparenchymal Infusion Cannula

FDA classification

FDA Class 2 ·Brain Intraparenchymal Infusion Cannula

Reagents For Detection Of Norovirus Nucleic Acid

FDA classification

FDA Class 2 ·Reagents For Detection Of Norovirus Nucleic Acid

Submucosal Injection Agent

FDA classification

FDA Class 2 ·Submucosal Injection Agent

PRAEZIS PLUS

FDA 510(k)

FDA Class 2 ·Neurology

Allix5

FDA 510(k)

FDA Class 2 ·Radiology

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

FDA classification

FDA Class 2 ·Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Digital Therapy Device For Amblyopia

FDA classification

FDA Class 2 ·Digital Therapy Device For Amblyopia

Capillary Blood Collection Device For Alternative Site Collection

FDA classification

FDA Class 2 ·Capillary Blood Collection Device For Alternative Site Collection

Assay, 1,5-Anhydroglucitol (15ag)

FDA classification

FDA Class 2 ·Assay, 1,5-Anhydroglucitol (15ag)

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Interoperable Automated Glycemic Controller

FDA classification

FDA Class 2 ·Interoperable Automated Glycemic Controller

Real Time Nucleic Acid Amplification System

FDA classification

FDA Class 2 ·Real Time Nucleic Acid Amplification System

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

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

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump