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Detector H. pylori

FDA UDI

Class I (US FDA UDI)

by Immunostics, Inc.

Identity

Trade Name
Detector H. pylori FDA UDI
Generic Name
Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
Device Name
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies FDA UDI
Model / Reference
IHP-10 FDA UDI
Description
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies FDA UDI

Identifiers

Primary DI / UDI-DI
10722355002016 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Detector H. pylori by Immunostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunostics, Inc.

Sources (1)

  • FDA UDI fa56c6ea-f029-42ee-84c4-2d8bc609b84f 35 fields · synced May 30, 2026