Definition: Culture Medium For GBS Detection
| Device Type ID | 3575 |
| Device Name | Gbs Culture Media, Selective And Differential |
| Physical State | Media (broth Or Plates) |
| Technical Method | Chromogenic Agar |
| Target Area | Not Applicable |
| Regulation Description | Selective Culture Medium. |
| 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 | 866.2360 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PQZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3575 |
| Device | Gbs Culture Media, Selective And Differential |
| Product Code | PQZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Selective Culture Medium. |
| CFR Regulation Number | 866.2360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARDY DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
False Positive Result | 2 |
| Total Device Problems | 4 |