FDA UDI
In Commercial Distribution
🇺🇸 United States
BD MAX™ Extended Enteric Bacterial Panel
DI: 00382904438128
·
Model: 443812
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD MAX™ Extended Enteric Bacterial Panel
- Primary DI
- 00382904438128
- Version / Model
- 443812
- Catalog Number
- 443812
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-03
- Public Version
- 4
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- f25f5717-e006-437c-98c0-ef6b167235dd
Device Description
Kit BD MAX EXT Enteric Bacterial Panel
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 |
|---|---|---|---|---|
| PCH | Gastrointestinal pathogen 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 | 00382904438128 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K214122 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius