DeviceClearance

Product code LIQ— Microbiology

ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL

Classification name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device class
Class 1
Regulation
21 CFR 866.3405
Advisory panel
Microbiology
Total cleared
33
First cleared
Most recent

Market context for product code LIQ

FDA has cleared 33 devices under product code LIQ between 1984 and 1999, filed by 23 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

Top applicants under product code LIQ

Recent clearances under product code LIQ

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