FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Difco™ QC Antigen Salmonella O Group A
DI: 00382902213017
·
Model: 221301
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Difco™ QC Antigen Salmonella O Group A
- Primary DI
- 00382902213017
- Version / Model
- 221301
- Catalog Number
- 221301
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-28
- Public Version
- 3
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- d0d9e186-ad3e-481d-91fc-513c052793ef
Device Description
BD Difco™ QC Antigen Salmonella O Group A
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| GRL | ANTIGENS, ALL GROUPS, SALMONELLA SPP. | Microbiology | 866.3550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51515 | Multiple Salmonella species culture isolate antigen IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from one or multiple species of Salmonella 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 | 00382902213017 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius