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Monovalent Somatic Salmonella Antisera - Vi Factor

FDA UDI

Class II (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Monovalent Somatic Salmonella Antisera - Vi Factor FDA UDI
Generic Name
Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles. FDA UDI
Model / Reference
PL.6040 FDA UDI
Description
A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles. FDA UDI

Identifiers

Catalog Number
PL.6040 FDA UDI
Primary DI / UDI-DI
05060472462268 FDA UDI
FDA Product Code
GRM FDA UDI
GMDN Term
Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical 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

No

FDA UDI

Prescription Use

No

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 antigen IVD, kit, rapid agglutination, clinical

Monovalent Somatic Salmonella Antisera - Vi Factor by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI 20c80ba4-0434-4c3b-909d-3f4aaad419f3 34 fields · synced Jun 6, 2026