Reagents For Detection Of Norovirus Nucleic Acid
The Reagents for Detection of Norovirus Nucleic Acid is a qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroups I and II from stool specimens collected from individuals with symptoms of acute gastroenteritis. It is an FDA Class 2 device regulated under 21 CFR 866.3990, requiring 510(k) premarket notification, within the Microbiology (MI) specialty. The product code is PIQ. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PIQ
- Device Class
- FDA class 2
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K171511 | RIDA GENE Norovirus GI/GII | Aug 21, 2017 | Substantially Equivalent | R-Biopharm AG |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.