FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROBACT GNB 12B STRIP (60 ID'S)
DI: 05032384127979
·
Model: MB1133A
·
OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MICROBACT GNB 12B STRIP (60 ID'S)
- Primary DI
- 05032384127979
- Version / Model
- MB1133A
- Company Name
- OXOID LIMITED
- Labeler DUNS
- 365355452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-04
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- 02a8dc39-d6ab-4a9e-b60c-d70fd2d8de72
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| LQM | Gram Negative Identification Panel | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61331 | Multiple bacteria species culture isolate identification control IVD, kit | A collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been 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 | 05032384127979 | GS1 |