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Diamedix 789-008

by Diamedix Corp.

Diamedix 789-008 is a Class I device made by Diamedix Corp., listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020440), 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 Number00817273020440 UDI-DI Date20 Sep 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  • Withdrawn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

Trade name
Diamedix
Generic name
Plasma protein IVD, control
Model / reference
789-008
Description
"789-008 EZ Complement Low Control"
Primary DI / UDI-DI
00817273020440
FDA product code
DHL
GMDN term
Plasma protein IVD, control
Device class
Class I
Regulation number
866.4100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Plasma protein IVD, control

Similar devices in this category

Other devices filed under Plasma protein IVD, control.

Other devices from Diamedix Corp.

  • Diamedix 720-380

    Class II

  • Diamedix 720-250

    Class II

  • Diamedix 720-540

    Class I

  • Diamedix 720-650

    Class I

See all devices from Diamedix Corp. →

Properties

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