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

Anti-Factor Xa Activity Test System, Apixaban

21 CFR 864.7295 / Hematology
FDA source (opens on fda.gov)

QLU is the FDA product code for Anti-Factor Xa Activity Test System, Apixaban, a class II device type, regulated under 21 CFR 864.7295. FDA's definition for this code reads: "A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QLU
Device name
Anti-Factor Xa Activity Test System, Apixaban
FDA definition
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Regulation
21 CFR 864.7295
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code QLU

By decision year
3 clearances under product code QLU with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QLU by decision year
YearClearances
20201
20231
20241

Applicants with the most clearances

Product code QLU
Applicants holding the most 510(k) clearances under product code QLU
ApplicantClearances
Instrumentation Laboratory Co.2
Siemens Healthcare Diagnostics Products Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code