Antigen, Invasive Fungal Pathogens
Device Code: 3516
Product Code(s):
NQZ Definition: Invasive Fungal Pathogen Assays Are Devices That Consist Of Antigens, Antisera, Or Proteases Used In Serological Assays For The Presumptive Diagnosis Of Fungal Infection In Serum Or Plasma. The Assay Is Indicated For Use In Patients With Symptoms Of,
Device Classification Information
| Device Type ID | 3516 |
| Device Name | Antigen, Invasive Fungal Pathogens |
| Regulation Description | Beta-glucan Serological Assays. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQZ |
| 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 | 3516 |
| Device | Antigen, Invasive Fungal Pathogens |
| Product Code | NQZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Beta-glucan Serological Assays. |
| CFR Regulation Number | 866.3050 [🔎] |
TPLC Last Update: 2019-04-02 20:31:33