System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
PEU is the FDA product code for System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen, a class II device type, regulated under 21 CFR 866.3373. FDA's definition for this code reads: "The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PEU
- Device name
- System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
- FDA definition
- The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
- Regulation
- 21 CFR 866.3373
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code PEU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code PEU| Applicant | Clearances |
|---|---|
| Cepheid | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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