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

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

21 CFR 866.6020 / Immunology
FDA source (opens on fda.gov)

NQI is the FDA product code for System, Immunomagnetic, Circulating Cancer Cell, Enumeration, a class II device type, regulated under 21 CFR 866.6020. FDA's definition for this code reads: "In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
NQI
Device name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
FDA definition
In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.
Regulation
21 CFR 866.6020
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
No
Ingested clearances
13
Ingested recalls
9

Clearances, product code NQI

By decision year
13 clearances under product code NQI with a decision year between 2004 and 2013, 2005 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NQI by decision year
YearClearances
20041
20053
20062
20071
20081
20101
20111
20122
20131

Applicants with the most clearances

Product code NQI
Applicants holding the most 510(k) clearances under product code NQI
ApplicantClearances
Veridex, LLC10
Immunicon Corp.2
Advanced Diagnostic Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code