FDA 510(k)

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

Numéro K : K181205 · 2018-09-20

DemandeurCenters for Disease Control and Prevention

Date de décision2018-09-20

Code produitPBK

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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 2018-09-20 under 510(k) number K181205. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2018-09-20. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K181205.

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 2018-09-20, under 510(k) number K181205.

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.

Essais cliniques associés

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Autres dossiers indiquant Centers for Disease Control and Prevention en tant que demandeur

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

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Dispositifs connexes (Code : PBK)

K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention K221834Non-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

Source officielle

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