Investigational Use Only - Microbiology
The Investigational Use Only - Microbiology product code is assigned to microbiology diagnostic devices that are for investigational use only and for products imported into the United States only; these devices have not completed the FDA's standard device classification process. The device is currently not classified (Class N) and has no assigned regulation number or medical specialty description. This classification enables the importation and use of uncleared investigational microbiology devices in clinical research settings. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCY
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 7
Device Characteristics
Definition
Investigational use only and for products imported into the US only.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.