Identity
- Trade Name
- Prolex E. coli Non-O157 Identification Kit FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
- Device Name
- The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks. FDA UDI
- Model / Reference
- PL.1070 FDA UDI
- Description
- The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks. FDA UDI
Identifiers
- Catalog Number
- PL.1070 FDA UDI
- Primary DI / UDI-DI
- 10628429001124 FDA UDI
- FDA Product Code
- GNA FDA UDI
- GMDN Term
- Escherichia coli antigen IVD, kit, agglutination 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
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
Category: Escherichia coli antigen IVD, kit, agglutination
Prolex E. coli Non-O157 Identification Kit by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 58093b9e-727a-4766-814b-09cd2d1e2284 34 fields · synced Jun 8, 2026