Container, Specimen, Non-Sterile
The non-sterile specimen container is a pathology device used to collect and hold biological specimens such as tissue samples, body fluids, or other materials for laboratory analysis. It is classified as FDA Class 1 under regulation 864.3250 in the Pathology specialty, and it is GMP exempt, representing the lowest regulatory burden. Product code NNI does not require 510(k) clearance (submission type 4 indicates 510(k) exempt status) and is not indicated for implant or life-sustaining use.
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Basic Information
- Product Code
- NNI
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 329 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 329 registration numbers. Click on an entry to view related FDA registrations.