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Nano-Check Influenza+COVID-19 Dual Test MD8154

by Nano-Ditech Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00895160002960 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nano-Check Influenza+COVID-19 Dual Test
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
Model / Reference
MD8154
Primary DI / UDI-DI
00895160002960
FDA Product Code
SCA
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
866.3987
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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