Enviar RFQ
EnglishEspañol
Enviar RFQ

Documento fuente o registro público

FDA 510(k) K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k) index record K243759. Device: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)). Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2024-12-20.

OtherU.S. Food and Drug Administration (FDA)2024-12-20

Fuente

"device_name": "BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

professional use

References

FDA 510(k) public index record K243759.

Device name: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)). Applicant as listed: Biofire Diagnostics, LLC.

Decision date: 2024-12-20. Decision wording: Substantially Equivalent.

Product code: PEN. Regulation: 21 CFR 866.3365. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.

Solicitar cotización

Explorar más

Misma fuente

FDA 510(k) K262432 — CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

FDA 510(k) index record K262432. Device: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test. Applicant as listed: CorDx, In…

Misma fuente

FDA 510(k) K262576 — twiist Loop Algorithm

FDA 510(k) index record K262576. Device: twiist Loop Algorithm. Applicant as listed: Deka Research and Development Corp.. Decision date: 2026-10-15.

Misma fuente

FDA 510(k) K260827 — Oncomine ™ Dx Express Test

FDA 510(k) index record K260827. Device: Oncomine ™ Dx Express Test. Applicant as listed: Life Technologies Corporation. Decision date: 2026-10-15.