Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
The Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid (product code POG) are nucleic acid-based in vitro diagnostic devices intended for the presumptive detection and identification of Ebola Zaire virus in human clinical specimens. The product is currently unclassified (Class N) with no regulation number or formal medical specialty description assigned. The devices are not implants and are not life-sustaining.
Research product code POG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- POG
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 8
Device Characteristics
Definition
Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens
Unclassified Reason
11
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.