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Diamedix 789-009

by Diamedix Corp.

Diamedix 789-009 is a Class I device made by Diamedix Corp., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00817273020457), 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 Number00817273020457 UDI-DI Date21 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  • Withdrawn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
789-009
Description
"789-009 EZ Complement High Control"
Primary DI / UDI-DI
00817273020457
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

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Other devices from Diamedix Corp.

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Properties

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