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QMedix™ DACD1301-1

by Diagnostic Automation, Inc.

QMedix™ DACD1301-1 is a Class II device made by Diagnostic Automation, Inc., listed in FDA GUDID since 2 Feb 2024 (UDI-DI 00850054026019), 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 Number00850054026019 UDI-DI Date2 Feb 2024ListedStatusListed 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  • Withdrawn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
QMedix™
Generic name
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
DACD1301-1, 1301-1
Primary DI / UDI-DI
00850054026019
FDA product code
OPL
GMDN term
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3510
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code OPL (Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus).

Other devices from Diagnostic Automation, Inc.

See all devices from Diagnostic Automation, Inc. →

Properties

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