Definition: Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment
| Device Type ID | 6245 |
| Device Name | Drug Metabolizing Enzyme Genotyping Systems |
| Regulation Description | Drug Metabolizing Enzyme Genotyping System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 6245 |
| Device | Drug Metabolizing Enzyme Genotyping Systems |
| Product Code | NTI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Drug Metabolizing Enzyme Genotyping System. |
| CFR Regulation Number | 862.3360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX MOLECULAR DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nanosphere, Inc. | III | Aug-28-2014 |