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Diamedix

FDA UDI

Class II (US FDA UDI)

by Diamedix Corp.

Identity

Trade Name
Diamedix FDA UDI
Generic Name
Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
"720-440 anti-PR-3 (C-ANCA) IgG Test Kit" FDA UDI
Model / Reference
720-440 FDA UDI
Description
"720-440 anti-PR-3 (C-ANCA) IgG Test Kit" FDA UDI

Identifiers

Primary DI / UDI-DI
00817273020259 FDA UDI
510(k) Number
K983390 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diamedix Corp.

Sources (1)

  • FDA UDI 34c158f0-cb2e-49f8-b7ca-ffa68e4fa47e 36 fields · synced May 30, 2026