Alpha-d-glucosidase (gaa) Newborn Screening Test System
Device Code: 668
Product Code(s):
PQU Definition: For Quantitative Measurement Of The Activity Of Alpha-D-glucosidase (GAA) From Newborn Dried Blood Spot Specimens.
Device Classification Information
| Device Type ID | 668 |
| Device Name | Alpha-d-glucosidase (gaa) Newborn Screening Test System |
| Physical State | Neonatal Screening Test |
| Technical Method | Quantitative Fluorimetric Enzymatic Activity Assay. |
| Target Area | Newborn Dried Blood Spot Specimens |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1488 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 668 |
| Device | Alpha-d-glucosidase (gaa) Newborn Screening Test System |
| Product Code | PQU |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1488 [🔎] |
TPLC Last Update: 2019-04-02 19:38:22