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

Adalimumab Assay

21 CFR 862.3115 / Clinical Toxicology
FDA source (opens on fda.gov)

QYD is the FDA product code for Adalimumab Assay, a class II device type, regulated under 21 CFR 862.3115. FDA's definition for this code reads: "An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QYD
Device name
Adalimumab Assay
FDA definition
An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody
Regulation
21 CFR 862.3115
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QYD

By decision year
1 clearance under product code QYD with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYD by decision year
YearClearances
20231

Applicants with the most clearances

Product code QYD
Applicants holding the most 510(k) clearances under product code QYD
ApplicantClearances
Procisedx, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code