Skip to content

Fort Worth Diagnostics BORPOS

by Fort Worth Diagnostics LLC

Fort Worth Diagnostics BORPOS is a borrelia burgdorferi nucleic acid IVD (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Fort Worth Diagnostics LLC, listed in FDA GUDID since 20 Jun 2025 (UDI-DI 00850051429608), 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 Number00850051429608 UDI-DI Date20 Jun 2025ListedStatusListed 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  • Withdrawn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
Borrelia burgdorferi nucleic acid IVD, control
Model / Ref / Catalog
BORPOS
Primary DI / UDI-DI
00850051429608
FDA product code
JJX
GMDN term
Borrelia burgdorferi nucleic acid IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Borrelia burgdorferi nucleic acid IVD, control

Similar devices

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

Other devices from Fort Worth Diagnostics LLC

See all devices from Fort Worth Diagnostics LLC →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)