Verigene Respiratory Virus Nucleic Acid Test

by Nanosphere, Inc. 510(k)

Active United States

510(k) K083088

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK083088	Date1 May 2009Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K083088
FDA Product Code: OCC

Device Class: Class II
Regulation: 21 CFR Part 866.3980
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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