FDA UDI
In Commercial Distribution
🇺🇸 United States
CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS
DI: 08033891322779
·
Model: 82308
·
DIESSE DIAGNOSTICA SENESE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS
- Primary DI
- 08033891322779
- Version / Model
- 82308
- Catalog Number
- 82308
- Company Name
- DIESSE DIAGNOSTICA SENESE SPA
- Labeler DUNS
- 435036669
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-19
- Public Version
- 1
- Public Version Date
- 2025-08-27
- Public Version Status
- New
- Public Device Record Key
- f7350212-1fa9-4898-8d07-e9a46c5babd3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50832 | Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033891322779 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 2 Degrees Celsius