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Diamedix

FDA UDI

Class II (US FDA UDI)

by Diamedix Corp.

Identity

Trade Name
Diamedix FDA UDI
Generic Name
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
720-130 H.pylori IgG Test Kit FDA UDI
Model / Reference
720-130 FDA UDI
Description
720-130 H.pylori IgG Test Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00817273020051 FDA UDI
510(k) Number
K970220 FDA UDI
FDA Product Code
LLL FDA UDI
GMDN Term
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control 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

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

Yes

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: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, controlHelicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K970220 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diamedix Corp.

Sources (1)

  • FDA UDI d42c5717-06e7-4982-8c74-0b6d6dfaea48 36 fields · synced Jun 8, 2026