510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120014Unknown

Verigene Gram Positive Blood Culture Nucleic Acid Test (Bc-Gp)

Luminex Corporation, Northbrook IL / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120014 is the FDA 510(k) clearance record for VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP), a class II device, cleared for Nanosphere, Inc. on under FDA product code PAM (Gram-Positive Bacteria And Their Resistance Markers). FDA's definition for product code PAM reads: "A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures". FDA records list 34 510(k) clearances for Luminex Corporation, from to . As of , FDA records show no recalls naming DEN120014.

Clearance record

Decision date
Received
(11 days to decision)
Product code
PAM Gram-Positive Bacteria And Their Resistance Markers
Regulation
21 CFR 866.3365
Device class
Class II
Review panel
Microbiology
Applicant
Nanosphere, Inc. 4088 Commercial Ave., Northbrook IL
Third party review
No

Clearances, product code PAM

Trailing 12 months
1 clearance under product code PAM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260