Diamedix

FDA UDI

Class II (US FDA UDI)

by Diamedix Corp.

Identity

Trade Name: Diamedix FDA UDI
Generic Name: Nucleic acid hybridization detection IVD, kit FDA UDI
Device Name: "720-700 anti-dsDNA Test Kit" FDA UDI
Model / Reference: 720-700 FDA UDI
Description: "720-700 anti-dsDNA Test Kit" FDA UDI

Identifiers

Primary DI / UDI-DI: 00817273020372 FDA UDI
510(k) Number: K994424 FDA UDI
FDA Product Code: LRM FDA UDI
GMDN Term: Nucleic acid hybridization detection IVD, kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5100 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nucleic acid hybridization detection IVD, kit

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

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Cleared under the same submission

K994424 also covers:

Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit — Gold Standard Diagnostics, LLC

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 II	Pending data

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Manufacturer

Manufacturer: Diamedix Corp.

Sources (1)

FDA UDI ae396f54-1732-4d1a-90fd-c0394336c51f 36 fields · synced May 30, 2026