Identity
- Trade Name
- PREMIER EHEC FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections. FDA UDI
- Model / Reference
- 608096 FDA UDI
- Description
- The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections. FDA UDI
Identifiers
- Catalog Number
- 608096 FDA UDI
- Primary DI / UDI-DI
- 00840733101724 FDA UDI
- FDA Product Code
- GNA 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)
Premier Ehec 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).
- SHIGA TOXIN QUIK CHEK — TECHLAB, INC. · Class I
- SHIGA TOXIN CHEK — TECHLAB, INC. · Class I
- ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay — REMEL EUROPE LIMITED · Class I
- ImmunoCard STAT E. coli O157 Plus — MERIDIAN BIOSCIENCE, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI d4920e1a-de7d-4cf9-9dd8-4562e823e0f8 36 fields · synced May 30, 2026