Diamedix

FDA UDI

Class I (US FDA UDI)

by Diamedix Corp.

Identity

Trade Name: Diamedix FDA UDI
Generic Name: Plasma protein IVD, control FDA UDI
Device Name: "789-009 EZ Complement High Control" FDA UDI
Model / Reference: 789-009 FDA UDI
Description: "789-009 EZ Complement High Control" FDA UDI

Identifiers

Primary DI / UDI-DI: 00817273020457 FDA UDI
FDA Product Code: DHL FDA UDI
GMDN Term: Plasma protein IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.4100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Plasma protein IVD, control

Diamedix by Diamedix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Diamedix Corp.

Sources (1)

FDA UDI e231a9ea-2442-47aa-ac90-b760dacdb516 35 fields · synced Jun 6, 2026