FDA UDI
In Commercial Distribution
🇺🇸 United States
Polyvalent Shigella Slide Antisera - dysenteriae 1-10
DI: 05060472462732
·
Model: PL.6902
·
PRO-LAB, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Polyvalent Shigella Slide Antisera - dysenteriae 1-10
- Primary DI
- 05060472462732
- Version / Model
- PL.6902
- Catalog Number
- PL.6902
- Company Name
- PRO-LAB, INCORPORATED
- Labeler DUNS
- 960418395
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 1
- Public Version Date
- 2022-12-28
- Public Version Status
- New
- Public Device Record Key
- 02074b15-e8cc-4823-b590-29816583a6a3
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GNB | Antisera, All Types, Shigella Spp. | Microbiology | 866.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51623 | Shigella dysenteriae culture isolate antigen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Shigella dysenteriae bacteria isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060472462732 | GS1 |