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Curian HpSA

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Curian HpSA FDA UDI
Generic Name
Helicobacter pylori total antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. FDA UDI
Model / Reference
760130 FDA UDI
Description
Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. FDA UDI

Identifiers

Catalog Number
760130 FDA UDI
Primary DI / UDI-DI
00840733102271 FDA UDI
510(k) Number
K192817 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori total antibody IVD, kit, fluorescent immunoassay 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 total antibody IVD, kit, fluorescent immunoassay

Curian HpSA by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI ae49abf3-b798-4107-a3f7-ec0bfb1044e6 37 fields · synced May 31, 2026