Product code GRA— Microbiology

ANTIBODY TO MUMPS VIRUS IFA TEST

Classification name: Antiserum, Fluorescent, Mumps Virus
Device class: Class 1
Regulation: 21 CFR 866.3380
Advisory panel: Microbiology
Total cleared: 3
First cleared: 1977-03-01
Most recent: 1989-10-16

Market context for product code GRA

FDA has cleared 3 devices under product code GRA between 1977 and 1989, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19891 clearance
19821 clearance
19771 clearance

Top applicants under product code GRA

Flow Laboratories, Inc.1 clearance
Electro-Nucleonics Laboratories, Inc.1 clearance
Bion Ent., Ltd.1 clearance

Recent clearances under product code GRA

K894624 — MUMPS VIRUSBion Ent., Ltd.·1989-10-16
K822826 — ANTIBODY TO MUMPS VIRUS IFA TESTElectro-Nucleonics Laboratories, Inc.·1982-12-03
K770216 — VIRAL ANTISERA, FLUORESCEIN LABELEDFlow Laboratories, Inc.·1977-03-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.