Antigen, Galactomannan, Aspergillus Spp.
Device Code: 3513
Product Code(s):
NOM Definition: The Platelia Aspergillus EIA Is An Immunoenzymatic Sandwich Microplate Assay For The Detection Of Aspergillus Galactomannan Antigen In Human Serum. It Is A Test Which, When Used In Conjunction With Other Diagnostic Procedures Such As Microbiological
Device Classification Information
| Device Type ID | 3513 |
| Device Name | Antigen, Galactomannan, Aspergillus Spp. |
| Regulation Description | Aspergillus Spp. Serological Reagents. |
| 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 | 866.3040 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NOM |
| 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 | 3513 |
| Device | Antigen, Galactomannan, Aspergillus Spp. |
| Product Code | NOM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Aspergillus Spp. Serological Reagents. |
| CFR Regulation Number | 866.3040 [🔎] |
TPLC Last Update: 2019-04-02 20:31:29