Anti-HCV Next
by Abbott Laboratories 510(k)
Active
510(k) K252424
Overview
The Anti-HCV Next is an enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to hepatitis C virus (HCV). It is classified as a Class II medical device under regulation number 866.3169 and product code MZO.
The device is intended for use in laboratory settings to aid in the presumptive diagnosis of HCV infection when used alongside other laboratory results and clinical information. It is supplied as a kit for in vitro diagnostic use and has received FDA 510(k) clearance (K252424) as substantially equivalent to a legally marketed predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252424 | Date28 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MZO
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3169
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Anti-HCV Next used for?
The Anti-HCV Next is an enzyme-linked immunosorbent assay (ELISA) intended for use in laboratory settings to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection when used alongside other laboratory results and clinical information.
How is the Anti-HCV Next supplied and what type of test is it?
The Anti-HCV Next is supplied as a kit for in vitro diagnostic use and is classified as an enzyme-linked immunosorbent assay (ELISA) designed to detect antibodies to hepatitis C virus in serum or plasma samples.
Is the Anti-HCV Next a single-use or reusable device?
The Anti-HCV Next is supplied as a kit for in vitro diagnostic use, indicating it is intended for single-use testing runs; reagents and components are consumed during the assay process and not intended for reuse.