FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Enteric Bacterial Panel plus for BD COR™ System
DI: 00382904448721
·
Model: 444872
·
BECTON, DICKINSON AND COMPANY
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BD Enteric Bacterial Panel plus for BD COR™ System
- Primary DI
- 00382904448721
- Version / Model
- 444872
- Catalog Number
- 444872
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-09
- Public Version
- 1
- Public Version Date
- 2025-12-17
- Public Version Status
- New
- Public Device Record Key
- cc23a5d6-93f4-4c0b-810f-9c35f5dd4c93
Device Description
BD Enteric Bacterial Panel plus for BD COR™ System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OOI | real time Nucleic acid amplification system | Clinical Chemistry | 862.2570 | 2 |
| PCH | Gastrointestinal pathogen panel multiplex nucleic acid-based assay system | Microbiology | 866.3990 | 2 |
| PCI | Gastrointestinal bacterial panel multiplex nucleic acid-based assay system | Microbiology | 866.3990 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47381 | Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904448721 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250358 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- P403+P233: Store in a well-ventilated place. Keep container tightly closed
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Special Storage Condition, Specify
- Special Conditions
- P405 – Store locked up.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care