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ImmunoCard STAT! HpSA

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
ImmunoCard STAT! HpSA FDA UDI
Generic Name
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. FDA UDI
Model / Reference
750220 FDA UDI
Description
The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. FDA UDI

Identifiers

Catalog Number
750220 FDA UDI
Primary DI / UDI-DI
00840733101380 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori antigen 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

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 antigen IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Helicobacter pylori antigen IVD, kit, rapid ICT, clinical.

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 a58e8be3-795c-4276-b73e-1ff399e12c6e 35 fields · synced May 30, 2026