Identity
- Trade Name
- Vision 2 FDA UDI
- Generic Name
- Multiple Salmonella species culture isolate antigen IVD, reagent FDA UDI
- Device Name
- Salmonella H: 1,w For phase inversion FDA UDI
- Model / Reference
- PLA249 FDA UDI
- Description
- Salmonella H: 1,w For phase inversion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817978022497 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
Single Use
Yes
Implantable
No
Contains Latex
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple Salmonella species culture isolate antigen IVD, reagent
The Vision 2 medical device is a laboratory instrument designed for the qualitative and quantitative detection of Salmonella antigens from multiple species isolated by culture. It features phase inversion, making it suitable for various assays. The device has an expiration date and is marketed for use in microbiology.
Similar devices
Also classified as Multiple Salmonella species culture isolate antigen IVD, reagent.
- 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
- 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
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 435a881e-76ec-4e3d-9acd-f1bc8e06bb07 35 fields · synced Jun 22, 2026