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ImmunoCard STAT E. coli O157 Plus

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
ImmunoCard STAT E. coli O157 Plus FDA UDI
Generic Name
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use. FDA UDI
Model / Reference
750530 FDA UDI
Description
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use. FDA UDI

Identifiers

Catalog Number
750530 FDA UDI
Primary DI / UDI-DI
00840733101816 FDA UDI
510(k) Number
K023599 FDA UDI
FDA Product Code
GMZ FDA UDI
GMDN Term
Escherichia coli antigen 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

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: Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

ImmunoCard STAT E. coli O157 Plus by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA).

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 b1fa9f3d-1096-4ec3-9038-9921675cd506 37 fields · synced May 30, 2026