EZ-SALMONELLA One-Step Salmonella species Rapid Test (UDI 1007-15)
Manufactured by BIOMERICA, INC.
Device Regulatory Overview
The EZ-SALMONELLA One-Step Salmonella species Rapid Test (Model/Catalog Number: 1007-15) is a medical device manufactured by BIOMERICA, INC.. This product is indexed under FDA Product Code / Category Classification GRM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1007-15
- Product Code / EMDN
- GRM
- 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.
- Database Sync Date
- 2026-08-09 09:08:44
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of EZ-SALMONELLA One-Step Salmonella species Rapid Test?
The registered manufacturer of record for EZ-SALMONELLA One-Step Salmonella species Rapid Test is BIOMERICA, INC..
What is the Primary UDI-DI identifier for EZ-SALMONELLA One-Step Salmonella species Rapid Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1007-15.
What classification code is assigned to this device?
This device is registered under product classification code GRM.
Similar Classification Devices (GRM)
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