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FDA PMA

Opioid use disorder genetic risk variant detection system and collection kit

Número do PMA: P230032 · 2026-05-20

RequerenteAutoGenomics, Inc.
Data da decisão2026-05-20
Número PMAP230032
Código do produtoQZH
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoTX

Resumo do dispositivo

Opioid use disorder genetic risk variant detection system and collection kit is the device name listed in this FDA 510(k) record. The listed applicant is AutoGenomics, Inc.. It received FDA 510(k) clearance on 2026-05-20. The device is classified under product code QZH. It was reviewed by the TX advisory panel.

Perguntas frequentes

What is the Opioid use disorder genetic risk variant detection system and collection kit?

Opioid use disorder genetic risk variant detection system and collection kit is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is AutoGenomics, Inc..

When did Opioid use disorder genetic risk variant detection system and collection kit receive FDA 510(k) clearance?

The clearance date for Opioid use disorder genetic risk variant detection system and collection kit can be found in the official FDA records.

Who is the listed applicant for Opioid use disorder genetic risk variant detection system and collection kit?

The FDA 510(k) record lists AutoGenomics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Opioid use disorder genetic risk variant detection system and collection kit?

The FDA product code for Opioid use disorder genetic risk variant detection system and collection kit is QZH.

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Fonte oficial

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