Identity
- Trade Name
- Vision 2 FDA UDI
- Generic Name
- Multiple Salmonella species culture isolate antigen IVD, reagent FDA UDI
- Device Name
- Salmonella H: 1 complex FDA UDI
- Model / Reference
- PLA128 FDA UDI
- Description
- Salmonella H: 1 complex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817978021285 FDA UDI
- FDA Product Code
- GNC FDA UDI
- GMDN Term
- Multiple Salmonella species culture isolate antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3550 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Multiple Salmonella species culture isolate antigen IVD, reagent
Vision 2 by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Vision 2 — PRO-LAB, INCORPORATED · Class II
- Vision 2 — PRO-LAB, INCORPORATED · Class II
- Vision 2 — PRO-LAB, INCORPORATED · Class II
- Vision 2 — PRO-LAB, INCORPORATED · Class II
- Vision 2 — PRO-LAB, INCORPORATED · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 6fa271ee-0574-402e-bfda-986e5cad0f62 35 fields · synced May 31, 2026