Associates of Cape Cod, Inc.
FDA 510(k) medical device clearances, first cleared 2004, most recent 2019, with 2 FDA device recalls on record.
Top product codes for Associates of Cape Cod, Inc.
FDA recalls by Associates of Cape Cod, Inc.
- Z-1774-2022 — Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
- Z-1329-2019 — Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Associates of Cape Cod, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.