Last synced on 30 November 2024 at 11:09 am

Research Use Only/Microbiology

Page Type
Product Code
Definition
For research use only and for products imported into the US only.
Physical State
N/A
Technical Method
N/A
Target Area
N/A
Review Panel
Microbiology
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OTT is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Research Use Only/Microbiology

Page Type
Product Code
Definition
For research use only and for products imported into the US only.
Physical State
N/A
Technical Method
N/A
Target Area
N/A
Review Panel
Microbiology
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OTT is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.