ADVIA Centaur Enhanced Liver Fibrosis (ELF)

Prognostic Test For Assessment Of Liver Related Disease Progression

Siemens Healthcare Diagnostics Inc.

The following data is part of a De Novo classification by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Enhanced Liver Fibrosis (elf).

Pre-market Notification Details

• DeNovo ID: DEN190056
• Device Name: ADVIA Centaur Enhanced Liver Fibrosis (ELF)
• Classification: Prognostic Test For Assessment Of Liver Related Disease Progression
• Applicant: Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591
• Contact: Matthew Gee
• Product Code: QQB
• CFR Regulation Number: 862.1622 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Clinical Chemistry
• Classification Advisory: Clinical Chemistry
• Type: Direct
• Date Received: 2019-12-26
• Decision Date: 2021-08-20
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414618128	DEN190056	000
00630414618463	DEN190056	000