FDA 510(k)

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

N.º K: K221834 · 2022-06-24

SolicitanteCenters for Disease Control and Prevention

Fecha de decisión2022-06-24

Código de productoPBK

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K221834. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K221834.

When did Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set receive FDA 510(k) clearance?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set received FDA 510(k) clearance on 2022-06-24, under 510(k) number K221834.

Who is the listed applicant for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is PBK.

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Otros registros que enlistan a Centers for Disease Control and Prevention como solicitante

K260812Francisella tularensis Real-time PCR Assay K252072Francisella tularensis Real-time PCR assay K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: PBK)

K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.