GRA — Antiserum, Fluorescent, Mumps Virus Class I

FDA Device Classification

FDA product code GRA covers "Antiserum, Fluorescent, Mumps Virus", a Class I medical device regulated under 21 CFR 866.3380. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GRA
Device Class
Class I
Regulation Number
866.3380
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894624bion entMUMPS VIRUSOctober 16, 1989
K822826electro-nucleonics laboratoriesANTIBODY TO MUMPS VIRUS IFA TESTDecember 3, 1982
K770216flow laboratoriesVIRAL ANTISERA, FLUORESCEIN LABELEDMarch 1, 1977