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MCE — Respiratory Syncytial Virus - Elisa Class I

FDA Device Classification

FDA product code MCE covers "Respiratory Syncytial Virus - Elisa", a Class I medical device regulated under 21 CFR 866.3480. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MCE
Device Class
Class I
Regulation Number
866.3480
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K061008quidelQUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199September 8, 2006
K924289bio-rad laboratoriesKALLESTAD RSV MICROPLATE EIAFebruary 12, 1993

FDA data resources