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Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge 20-006-020

by Nanosphere, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857573006133 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2684-2014 FDA Class II initiated 10 Oct 2013

    Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Reference
20-006-020
Primary DI / UDI-DI
00857573006133
510(k) Number
FDA Product Code
OCC
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.3980
GUDID distribution status
Not in Commercial Distribution

Other devices from Nanosphere, Inc.

See all devices from Nanosphere, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No