Definition: Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.
| Device Type ID | 3549 |
| Device Name | C. Difficile Toxin Gene Amplification Assay |
| Physical State | Not Applicable |
| Technical Method | Uses Amplification Technology To Detect Toxin Genes Of C. Difficile |
| Target Area | Not Applicable |
| Regulation Description | Clostridium Difficile Toxin Gene Amplification Assay. |
| 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 | 866.3130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3549 |
| Device | C. Difficile Toxin Gene Amplification Assay |
| Product Code | OZN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Clostridium Difficile Toxin Gene Amplification Assay. |
| CFR Regulation Number | 866.3130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FOCUS DIAGNOSTICS, INC.: DBA DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QIAGEN, GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nanosphere, Inc. | II | Sep-23-2014 |
| 2 | Nanosphere, Inc. | III | Aug-08-2014 |