FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxoid™ Moxifloxacin Antimicrobial Susceptibility Disks
DI: 05032384140480
·
Model: CT1788S
·
OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxoid™ Moxifloxacin Antimicrobial Susceptibility Disks
- Primary DI
- 05032384140480
- Version / Model
- CT1788S
- Company Name
- OXOID LIMITED
- Labeler DUNS
- 365355452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-30
- Public Version
- 1
- Public Version Date
- 2020-02-07
- Public Version Status
- New
- Public Device Record Key
- cf5f3252-5135-4dc4-84dc-18211fb3eb28
Device Description
Manually determine the antibiotic susceptibility of microorganisms using Antimicrobial Susceptibility Testing (AST) methods in conjunction with reliable, easy-to-use Thermo Scientific™ Oxoid™ Moxifloxacin Antimicrobial Susceptibility Discs.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | Microbiology | 866.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63834 | Antibacterial susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05032384140480 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010536 | 000 |