| Proprietary Name: | Fungitell (cleared as Glucatell); FUNGITELL (CLEARED UND |
| Classification Name: | ANTIGEN, INVASIVE FUNGAL PATHOGENS |
| Product Code: | NQZ |
| Device Class: | 2 |
| Regulation Number: | 866.3050 |
| Medical Specialty: | Microbiology |
| Registered Establishment Name: | ASSOCIATES OF CAPE COD, INC. |
| Registered Establishment Number: | 1219145 |
| Premarket Submission Number: | DEN040003 |
| Owner/Operator: | ASSOCIATES OF CAPE COD, INC. |
| Owner/Operator Number: | 1219145 |
| Establishment Operations: | Manufacturer |