Research Use Only/Clinical Chemistry Devices
The Research Use Only/Clinical Chemistry Devices category (product code OTV) covers clinical chemistry devices and reagents intended for research use only and for products imported into the US only, not for clinical diagnostic purposes. These products are exempt from premarket clearance requirements. This product code is classified as FDA Not Classified, is GMP exempt, and has no associated regulation number or medical specialty. It is reviewed by the Clinical Chemistry panel. The devices are not implants and are not life-sustaining.
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Basic Information
- Product Code
- OTV
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 7
Device Characteristics
Definition
For research use only and for products imported into the US only.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.