Diamedix 789-006

by Diamedix Corp.

Diamedix 789-006 is a Class I device made by Diamedix Corp., listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020433), 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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817273020433 UDI-DI	Date20 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00817273020433

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Diamedix
Generic name: Plasma protein IVD, control
Model / reference: 789-006
Description: "789-006 EZ Complement Reference Serum"

Primary DI / UDI-DI: 00817273020433
FDA product code: DHL
GMDN term: Plasma protein IVD, control

Device class: Class I
Regulation number: 866.4100
GUDID distribution status: In Commercial Distribution

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Class I

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Properties

Convenience kit
Premarket exempt
Lot / batch number

Other properties (12, all answered No)