FDA Product Code SBP: Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test
A Simple Point-of-care Nucleic Acid-based Hepatitis C Virus (hcv) Ribonucleic Acid (rna) Test Is An In Vitro Diagnostic Device That Is Intended For Prescription Use For The Detection Of Hcv Rna In Clinical Specimens As An Aid In The Diagnosis Of Hcv Infection Or As An Aid In The Management Of Hcv-infected Patients, Including Individuals Without Antibodies To Hcv. This Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Test Is Not Intended For Use As A Donor Screening Test For The Presence Of Hcv Rna In Blood, Blood Products, Or Tissue Donors.
Leading manufacturers include Cepheid.
List of Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test devices (product code SBP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →