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LIAISON NES Group A Strep

by DiaSorin Molecular LLC

510(k) K260333

LIAISON NES Group A Strep is a Class II device made by DiaSorin Molecular LLC, cleared under FDA 510(k) K260333 on 15 Jun 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Dual Track NumberK260333 Date15 Jun 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PGX
FDA applicant
Diasorin Molecular, LLC
Device class
Class II
Regulation
21 CFR Part 866.2680
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K260333

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K260333
UDI-DISize and differences
LIAISON NES® Group A Strep Control Swab Kit NES2860
DiaSorin Molecular LLC
NES2860 / NES286020816101029079 —On the market
LIAISON NES® Group A Strep NES2850
DiaSorin Molecular LLC
NES2850 / NES285020816101029062 —On the market

Similar devices

Other devices filed under FDA product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System).

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