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Fort Worth Diagnostics LPNE002

by Fort Worth Diagnostics LLC

Fort Worth Diagnostics LPNE002 is an assay development analyte-specific reagent IVD (FDA Class I; FDA product code MVU, Reagents, Specific, Analyte) made by Fort Worth Diagnostics LLC, listed in FDA GUDID since 22 Jul 2026 (UDI-DI 00810227730006), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810227730006 UDI-DI Date22 Jul 2026ListedStatusListed 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  • Withdrawn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
Fort Worth Diagnostics
Generic name
Assay development analyte-specific reagent IVD
Model / Ref / Catalog
LPNE002
Primary DI / UDI-DI
00810227730006
FDA product code
MVU
GMDN term
Assay development analyte-specific reagent IVD
Device class
Class I
Regulation number
864.4020
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MVU (Reagents, Specific, Analyte).

Other devices from Fort Worth Diagnostics LLC

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Properties

  • Premarket exempt
Other properties (14, all answered No)