MCE · Class I · 21 CFR 866.3480

FDA Product Code MCE: Respiratory Syncytial Virus - Elisa

Leading manufacturers include Quidel Corp. and Bio-Rad Laboratories, Inc..

2
Total
2
Cleared
162d
Avg days
1993
Since

FDA 510(k) Cleared Respiratory Syncytial Virus - Elisa Devices (Product Code MCE)

2 devices
1–2 of 2
Cleared Sep 08, 2006
QUICKVUE RSV (20 TEST KIT), MODEL 20193
K061008
Quidel Corp.
Microbiology · 149d
Cleared Feb 12, 1993
KALLESTAD RSV MICROPLATE EIA
K924289
Bio-Rad Laboratories, Inc.
Microbiology · 175d

About Product Code MCE - Regulatory Context