FDA UDI
In Commercial Distribution
🇺🇸 United States
Selux AST Gram Negative Panel
DI: 00850031114029
·
Model: 01-80001
·
Selux Diagnostics, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Selux AST Gram Negative Panel
- Primary DI
- 00850031114029
- Version / Model
- 01-80001
- Company Name
- Selux Diagnostics, Inc.
- Labeler DUNS
- 079715313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 1
- Public Version Date
- 2024-12-30
- Public Version Status
- New
- Public Device Record Key
- 04fe91a3-aea7-4bcc-acf3-4c3d12b0dc66
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | Microbiology | 866.1640 | 2 |
| LTW | Susceptibility Test Cards, Antimicrobial | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56737 | Antimicrobial susceptibility analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850031114026 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00850031114029 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211748 | 000 |