← Back to catalogue
Monovalent Somatic Salmonella Antisera - Factor 55
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Monovalent Somatic Salmonella Antisera - Factor 55 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.6041 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.6041 FDA UDI
- Primary DI / UDI-DI
- 05060472462275 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 - Factor 55 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.
- Monovalent Flagella Salmonella Antisera - Factor 6 — PRO-LAB, INCORPORATED · Class II
- Monovalent Flagella Salmonella Antisera - Factor c — PRO-LAB, INCORPORATED · Class II
- Monovalent Flagella Salmonella Antisera - Z4 Complex — PRO-LAB, INCORPORATED · Class II
- Monovalent Somatic Salmonella Antisera - Group P, Factor 38 — PRO-LAB, INCORPORATED · Class II
- Monovalent Somatic Salmonella Antisera - Vi Factor — PRO-LAB, INCORPORATED · Class II
- Monovalent Somatic Salmonella Antisera - Group D, Factor 9 — PRO-LAB, INCORPORATED · Class II
- Monovalent Flagella Salmonella Antisera - Factor gp — PRO-LAB, INCORPORATED · Class II
- Monovalent Flagella Salmonella Antisera - Factor z15 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 91acf415-b7e3-42b6-b7c1-82513c2cf65a 34 fields · synced Jun 1, 2026