Identity
- Trade Name
- Polyvalent Shigella Slide Antisera - boydii 1-15 FDA UDI
- Generic Name
- Shigella boydii culture isolate antigen IVD, reagent FDA UDI
- Device Name
- Shigella are differentiated from the closely related Escherichia coli on the basis of pathogenicity, physiology and serology. Pro-Lab polyvalent Shigella antisera are intended to aid in the serological identification after culture, isolation and biochemical characterization of Shigella organisms. These antisera are prepared in rabbits using reference strains according to recognized guidelines, and absorbed to remove cross-reactions. Shigella antisera are supplied in 2.0 ml dropper bottles, in a ready to use format. FDA UDI
- Model / Reference
- PL.6903 FDA UDI
- Description
- Shigella are differentiated from the closely related Escherichia coli on the basis of pathogenicity, physiology and serology. Pro-Lab polyvalent Shigella antisera are intended to aid in the serological identification after culture, isolation and biochemical characterization of Shigella organisms. These antisera are prepared in rabbits using reference strains according to recognized guidelines, and absorbed to remove cross-reactions. Shigella antisera are supplied in 2.0 ml dropper bottles, in a ready to use format. FDA UDI
Identifiers
- Catalog Number
- PL.6903 FDA UDI
- Primary DI / UDI-DI
- 05060472462749 FDA UDI
- FDA Product Code
- GNB FDA UDI
- GMDN Term
- Shigella boydii culture isolate antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3660 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: Shigella boydii culture isolate antigen IVD, reagent
Polyvalent Shigella Slide Antisera - boydii 1-15 by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 d53ec560-4cf5-404d-b961-c13123e3b67c 34 fields · synced May 30, 2026