Abbott Plex-Id Flu Assay
FDA 510(k) K121003 · Abbott Laboratories
510(k) numberK121003
Submission
- Device name
- Abbott Plex-Id Flu Assay
- Applicant
- Abbott Laboratories
Des Plaines, IL, US - Received
- April 2, 2012
- Decision date
- December 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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Questions and answers
When was Abbott Plex-Id Flu Assay cleared by the FDA?
Abbott Plex-Id Flu Assay (K121003) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 263 days after the submission was received.
What is the product code of K121003?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.