510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OBZClass II

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

21 CFR 866.5130 / Immunology
FDA source (opens on fda.gov)

OBZ is the FDA product code for Alpha-1-Antitrypsin Kit, Qualitative Phenotype, a class II device type, regulated under 21 CFR 866.5130. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OBZ
Device name
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
FDA 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.
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code OBZ

By decision year
2 clearances under product code OBZ with a decision year between 2007 and 2022, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBZ by decision year
YearClearances
20071
20221

Applicants with the most clearances

Product code OBZ
Applicants holding the most 510(k) clearances under product code OBZ
ApplicantClearances
Helena Laboratories, Corp.1
Sebia1

Companies listing this code with FDA

Companies whose registered establishments list this code