ImmunoCard STAT! EHEC

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: ImmunoCard STAT! EHEC FDA UDI
Generic Name: Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections. FDA UDI
Model / Reference: 751630 FDA UDI
Description: ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections. FDA UDI

Identifiers

Catalog Number: 751630 FDA UDI
Primary DI / UDI-DI: 00840733101366 FDA UDI
510(k) Number: K062546 FDA UDI
FDA Product Code: GMZ FDA UDI
GMDN Term: Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.3255 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

Yes

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoCard STAT! EHEC 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

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: Meridian Bioscience, Inc.

Sources (1)

FDA UDI 14a92675-1b47-4c05-81ea-03ee3bca1038 35 fields · synced May 30, 2026