ß-galactocerebrosidase (galc) Newborn Screening Test System
Device Code: 682
Product Code(s):
QCM Definition: For Quantitative Measurement Of The Activity Of ß-galactocerebrosidase (GALC) From Newborn Dried Blood Spot Specimens As An Aid In Screening Newborns For Krabbe Disease.
Device Classification Information
| Device Type ID | 682 |
| Device Name | ß-galactocerebrosidase (galc) Newborn Screening Test System |
| Physical State | Neonatal Screening Test, In Vitro Diagnostic Device. |
| Technical Method | Quantitative Enzymatic Activity Assay. |
| Target Area | Newborn Dried Blood Spot Specimens. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1488 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCM |
| 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 | 682 |
| Device | ß-galactocerebrosidase (galc) Newborn Screening Test System |
| Product Code | QCM |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1488 [🔎] |
TPLC Last Update: 2019-04-02 19:38:37