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Vysis 07J04-001

by Abbott Molecular

Vysis 07J04-001 is a Class I device made by Abbott Molecular, listed in FDA GUDID since 15 Dec 2017 (UDI-DI 00884999026223), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999026223 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Vysis
Generic name
Nucleic acid hybridization detection IVD, control
Model / Ref / Catalog
07J04-001
Primary DI / UDI-DI
00884999026223
FDA product code
PPM
GMDN term
Nucleic acid hybridization detection IVD, control
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nucleic acid hybridization detection IVD, control

Similar devices

Other devices filed under FDA product code PPM (General purpose reagent).

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)