FDA 510(k)

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

Numéro K : K241110 · 2024-05-21

DemandeurCenters for Disease Control and Prevention

Date de décision2024-05-21

Code produitOZE

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) 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 2024-05-21 under 510(k) number K241110. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K241110.

When did CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) received FDA 510(k) clearance on 2024-05-21, under 510(k) number K241110.

Who is the listed applicant for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)?

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 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)?

The FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) is OZE.

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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)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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Dispositifs connexes (Code : OZE)

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)Centers for Disease Control and Prevention 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)Centers for Disease Control and Prevention K230236Lyra Influenza A+B AssayQuidel Corporation K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention K182513FluChip-8G Influenza A+B AssayIndevr, Inc.

Source officielle

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