XPERGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pump, Infusion, Pca

FDA classification

FDA Class 2 ·Pump, Infusion, Pca

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

Antigen, Inflammatory Response Marker, Sepsis

FDA classification

FDA Class 2 ·Antigen, Inflammatory Response Marker, Sepsis

Endoscope, Battery-Powered And Accessories

FDA classification

FDA Class 2 ·Endoscope, Battery-Powered And Accessories

Light, Catheter, Fiberoptic, Glass, Ureteral

FDA classification

FDA Class 2 ·Light, Catheter, Fiberoptic, Glass, Ureteral

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification

FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

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

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

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Enteral Specific Transition Connectors

FDA classification

FDA Class 2 ·Enteral Specific Transition Connectors

Enteral Syringes With Enteral Specific Connectors

FDA classification

FDA Class 2 ·Enteral Syringes With Enteral Specific Connectors

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Dna Genetic Analyzer

FDA classification

FDA Class 2 ·Dna Genetic Analyzer