Alpha-1-antitrypsin Kit, Qualitative Phenotype
Device Code: 3080
Product Code(s):
OBZ Definition: The Alpha-1-antitrypsin Qualitative Phenotype Test Result Is Used As An Aid In The Diagnosis Of Alpha-1-antitrypsin Deficiency In Conjunction With Clinical And Other Laboratory Findings. For In Vitro Diagnostic Use Only.
Device Classification Information
| Device Type ID | 3080 |
| Device Name | Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Physical State | A1AT Antibody Isoelectric Focusing Gel Qualitative Phenotype Kit And A1AT Qualitative Phenotype Control |
| Technical Method | Isoelectric Focusing Gel Qualitative Test. |
| Target Area | Blood Serum |
| Regulation Description | Alpha-1-antitrypsin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBZ |
| 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 | 3080 |
| Device | Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Product Code | OBZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Alpha-1-antitrypsin Immunological Test System. |
| CFR Regulation Number | 866.5130 [🔎] |
TPLC Last Update: 2019-04-02 20:23:33