Norovirus Serological Reagent

FDA classification

FDA Class 2 ·Norovirus Serological Reagent

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

FDA classification

FDA Class 2 ·Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Drug Metabolizing Enzyme Genotyping Systems

FDA classification

FDA Class 2 ·Drug Metabolizing Enzyme Genotyping Systems

Biliary Stent System For Benign Strictures

FDA classification

FDA Class 2 ·Biliary Stent System For Benign Strictures

Defect Measurement Tool

FDA classification

FDA Class 2 ·Defect Measurement Tool

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

FDA classification

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

Acute Kidney Injury Test System

FDA classification

FDA Class 2 ·Acute Kidney Injury Test System

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification

FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls

Flow Cytometric Test System For Hematopoietic Neoplasms

FDA classification

FDA Class 2 ·Flow Cytometric Test System For Hematopoietic Neoplasms

Zika Virus Serological Reagents

FDA classification

FDA Class 2 ·Zika Virus Serological Reagents

Non-Factor Replacement Product Test System

FDA classification

FDA Class 2 ·Non-Factor Replacement Product Test System

Rickettsia Spp. Nucleic Acid Based Detection Assay

FDA classification

FDA Class 2 ·Rickettsia Spp. Nucleic Acid Based Detection Assay

Dengue Serological Reagents

FDA classification

FDA Class 2 ·Dengue Serological Reagents

Gastrointestinal Capsule Endoscopy Analysis Software Device

FDA classification

FDA Class 2 ·Gastrointestinal Capsule Endoscopy Analysis Software Device

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Candida Species Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Candida Species Nucleic Acid Detection System

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances