Skip to content

DriDye 450

by Awareness Technology, Incorporated

DriDye 450 (E002-450) is a medical device (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Awareness Technology, Incorporated, listed in FDA GUDID since 30 Jun 2016 (UDI-DI 00850229007171), 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 Number00850229007171 UDI-DI Date30 Jun 2016ListedStatusListed 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  • Withdrawn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

Generic name
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Model / Ref / Catalog
450, E002-450
Primary DI / UDI-DI
00850229007171
FDA product code
JJX
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, single-use
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optical laboratory instrument performance standard calibrator/control IVD, single-use

Similar devices in this category

Other devices filed under Optical laboratory instrument performance standard calibrator/control IVD, single-use.

Other devices from Awareness Technology, Incorporated

See all devices from Awareness Technology, Incorporated →

Properties

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