| Device Type ID | 3466 |
| Device Name | Helicobacter Pylori |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3110 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LYR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3466 |
| Device | Helicobacter Pylori |
| Product Code | LYR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| CFR Regulation Number | 866.3110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN BIOSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TECHLAB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 7 |