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Nano-Check RSV Test
NANO-DITECH CORPORATION · Model MD8152 · UDI-DI 00895160002854
GQG
Prescription
10
510(k) clearances
29
Adverse events
3
Recalls
36
Facilities
Description
The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2004-02-18 | Binax, Inc. | Pouch integrity compromised |
| 2003-12-15 | Becton Dickinson & Co. | Diagnostic test kit may exhibit false positive results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.