DeviceClearance

Product code PUQ— Microbiology

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

Classification name
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.”

— U.S. Food and Drug Administration, device classification record for product code PUQ under 21 CFR 866.3510, via openFDA

Market context for product code PUQ

FDA has cleared 1 device under product code PUQ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PUQ

Recent clearances under product code PUQ

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