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EZ-SALMONELLA One-Step Salmonella species Rapid Test

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name
EZ-SALMONELLA One-Step Salmonella species Rapid Test FDA UDI
Generic Name
Multiple Salmonella species antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only. FDA UDI
Model / Reference
1007-15 FDA UDI
Description
The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only. FDA UDI

Identifiers

Primary DI / UDI-DI
08305901007151 FDA UDI
FDA Product Code
GRM FDA UDI
GMDN Term
Multiple Salmonella species antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3550 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

EZ-SALMONELLA One-Step Salmonella species Rapid Test by Biomerica, Inc. — Class II — 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
Biomerica, Inc.

Sources (1)

  • FDA UDI bf883c35-7387-434c-b595-b690439c6685 35 fields · synced May 30, 2026