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Fort Worth Diagnostics EHRDIA

by Fort Worth Diagnostics LLC

Fort Worth Diagnostics EHRDIA is an ehrlichia chaffeensis 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 27 Oct 2026 (UDI-DI 00810227730181), registry data as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810227730181 UDI-DI Date27 Oct 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  • Withdrawn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
Ehrlichia chaffeensis nucleic acid IVD, control
Model / Ref / Catalog
EHRDIA
Primary DI / UDI-DI
00810227730181
FDA product code
JJX
GMDN term
Ehrlichia chaffeensis nucleic acid IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

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)