DeviceClearance

Product code DDZ— Immunology

FLUORESCEIN CONJUGATED IMMUNOGLOBIN-

Classification name
Albumin, Fitc, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5040
Advisory panel
Immunology
Total cleared
4
First cleared
Most recent

Market context for product code DDZ

FDA has cleared 4 devices under product code DDZ between 1983 and 2005, filed by 4 applicant companies. 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.

Clearances per year

Top applicants under product code DDZ

Recent clearances under product code DDZ

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