Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
The temperature-controlled non-sterile specimen mailer and storage container is a pathology device designed to maintain specimens within a specified temperature range during transport or storage, protecting sample integrity. It is classified as FDA Class 1 under regulation 864.3250 in the Pathology specialty, and it is GMP exempt. Product code NNL does not require 510(k) clearance and is subject only to general controls.
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Basic Information
- Product Code
- NNL
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.