Strip, Test Isoniazid
The Isoniazid Test Strip is a point-of-care or laboratory diagnostic device used to detect the presence of isoniazid, a first-line antibiotic used to treat tuberculosis, in patient urine or other biological specimens, typically to assess medication adherence in tuberculosis treatment programs. It is classified as an Unclassified (Class U) device, meaning the FDA has not yet determined its classification, and no regulation number or medical specialty is assigned. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MIG
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- TX
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.