FDA 510(k)

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

Numéro K : K202755 · 2022-11-05

Date de décision2022-11-05

Code produitQDZ

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-11-05 under 510(k) number K202755. The device is classified under product code QDZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2022-11-05. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K202755.

When did Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack receive FDA 510(k) clearance?

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack received FDA 510(k) clearance on 2022-11-05, under 510(k) number K202755.

Who is the listed applicant for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

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

What is the FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack?

The FDA product code for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is QDZ.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Diasorin Molecular, LLC en tant que demandeur

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit K251978LIAISON NES FLU A/B, RSV & COVID-19 K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K220963Simplexa COVID-19 & Flu A/B Direct K212147Simplexa COVID-19 Direct K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

Voir tous les 13 dispositifs →

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.