DeviceClearance

Product code OBZ— Immunology

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

Classification name
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Device class
Class 2
Regulation
21 CFR 866.5130
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification definition

“The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.”

— U.S. Food and Drug Administration, device classification record for product code OBZ under 21 CFR 866.5130, via openFDA

Market context for product code OBZ

FDA has cleared 2 devices under product code OBZ between 2007 and 2022, filed by 2 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 OBZ

Recent clearances under product code OBZ

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