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Vision 2

FDA UDI

Class II (US FDA UDI)

by Pro-Lab, Incorporated

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

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

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 435a881e-76ec-4e3d-9acd-f1bc8e06bb07 35 fields · synced Jun 22, 2026