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Prolex E. coli O157 Latex Test Reagent Kit (50 tests)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Prolex E. coli O157 Latex Test Reagent Kit (50 tests) FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
- Device Name
- ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls. FDA UDI
- Model / Reference
- PL.070B FDA UDI
- Description
- ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls. FDA UDI
Identifiers
- Catalog Number
- PL.070B FDA UDI
- Primary DI / UDI-DI
- 10628429001049 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 O157 Latex Test Reagent Kit (50 tests) 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 9ccc0171-7727-43bb-9ef7-a7fc628340f7 34 fields · synced Jun 8, 2026