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DiskFISH DF30012

by Cellay, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM663DF300129 UDI-DI Date6 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  • Withdrawn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
DiskFISH
Generic Name
Nucleic acid hybridization detection IVD, probe
Model / Ref / Catalog
DF30012
Primary DI / UDI-DI
M663DF300129
FDA Product Code
MVU
GMDN Term
Nucleic acid hybridization detection IVD, probe
Device Class
Class I
Regulation Number
864.4020
GUDID distribution status
In Commercial Distribution

Other devices from Cellay, Inc.

See all devices from Cellay, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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