SCoV-2 Ag Detect Rapid Test— 510(k) K233358

Name: FDA 510(k) clearance K233358
Creator: U.S. Food and Drug Administration
Published: 2024-08-23

Substantially Equivalent

InBios International, Inc.

FDA 510(k) clearance K233358 for SCoV-2 Ag Detect Rapid Test, Substantially Equivalent on 2024-08-23. Applicant: InBios International, Inc.. Device class: 2.

Clearance details

Applicant: InBios International, Inc.
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2023-09-29
Decision date: 2024-08-23
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QVF

view all

K254264 — Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA2026-09-04
K253882 — CorDx Tyfast COVID-19 Ag Rapid Test Rx2026-06-01
K251289 — WELLlife COVID-19 Antigen Test Rx2025-10-22
K243872 — BD Veritor System for SARS-CoV-22025-06-16
K250273 — BinaxNOW COVID-19 Ag Card2025-06-13

More clearances from InBios International, Inc.

view all

K251595 — COVID-19 Detect Rapid Self -Test2025-10-12
DEN220044 — Active Anthrax DetectTM Plus Rapid Test2023-02-03
DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA2019-05-23
K181473 — DENV Detect NS1 ELISA2018-08-27
K161947 — Chagas Detect Plus Rapid Test2016-12-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.