Assay, 1,5-anhydroglucitol (15ag)
Device Code: 2427
Product Code(s):
NOZ Definition: The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15AG) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes.
Device Classification Information
| Device Type ID | 2427 |
| Device Name | Assay, 1,5-anhydroglucitol (15ag) |
| Regulation Description | Glycosylated Hemoglobin Assay. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2427 |
| Device | Assay, 1,5-anhydroglucitol (15ag) |
| Product Code | NOZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glycosylated Hemoglobin Assay. |
| CFR Regulation Number | 864.7470 [🔎] |
TPLC Last Update: 2019-04-02 20:11:49