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FDA PMA

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

Número do PMA: P190033 · 2024-10-04

RequerenteARUP Laboratories
Data da decisão2024-10-04
Número PMAP190033
Código do produtoQWQ
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoHE

Resumo do dispositivo

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is the device name listed in this FDA 510(k) record. The listed applicant is ARUP Laboratories. It received FDA 510(k) clearance on 2024-10-04. The device is classified under product code QWQ. It was reviewed by the HE advisory panel.

Perguntas frequentes

What is the Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is ARUP Laboratories.

When did Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors receive FDA 510(k) clearance?

The clearance date for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors can be found in the official FDA records.

Who is the listed applicant for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

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

What is the FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?

The FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is QWQ.

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