510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K243489Substantially Equivalent

Alinity m EBV (09N43-095)

Abbott Molecular, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243489 is the FDA 510(k) clearance record for Alinity m EBV (09N43-095), a class II device, cleared for Abbott Molecular, Inc. on under FDA product code QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna). FDA's definition for product code QLX reads: "A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid...". FDA records list 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show no recalls naming K243489.

Clearance record

Decision date
Received
(258 days to decision)
Product code
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Regulation
21 CFR 866.3183
Device class
Class II
Review panel
Microbiology
Applicant
Abbott Molecular, Inc. 1300 E Touhy Ave., Des Plaines IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLX

Trailing 12 months

FDA records hold no clearances under product code QLX in the trailing twelve months.

FDA records show no clearances under product code QLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QLX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260