Teco Diagnostics H. pylori Card Test

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics H. pylori Card Test FDA UDI
Generic Name: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
Device Name: Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections. FDA UDI
Model / Reference: H730-A FDA UDI
Description: Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections. FDA UDI

Identifiers

Catalog Number: H730-A FDA UDI
Primary DI / UDI-DI: 10673486002393 FDA UDI
510(k) Number: K024360 FDA UDI
FDA Product Code: LYR FDA UDI
GMDN Term: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical 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

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Single Use

Yes

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

Yes

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Category: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Teco Diagnostics H. pylori Card Test by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Teco Diagnostics

Sources (1)

FDA UDI d1da0287-dc7f-4689-8234-7dddbf70e200 37 fields · synced May 30, 2026