FDA UDI
In Commercial Distribution
🇺🇸 United States
LSGN
DI: 00860012092116
·
Model: LS6503
·
Affinity Biosensors, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LSGN
- Primary DI
- 00860012092116
- Version / Model
- LS6503
- Company Name
- Affinity Biosensors, LLC
- Labeler DUNS
- 802576830
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-14
- Public Version
- 1
- Public Version Date
- 2025-10-22
- Public Version Status
- New
- Public Device Record Key
- b2e32bd5-939e-454f-9730-98523d2bc93f
Device Description
LifeScale Gram Negative Kit (LSGN) is used with the LifeScale AST system for testing positive blood culture samples containing gram-negative bacilli.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | Microbiology | 866.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63870 | Multiple-type pathogen antimicrobial susceptibility testing kit IVD | A collection of reagents and other associated materials containing a range of antimicrobial agents e.g., (antibacterial/antibiotic, antifungal/antimycotic and/or antimycobacterial) that may be impregnated on individual testing discs, in a strip format or a microplate, intended to be used to determine the susceptibility profile of a specific pathogen (bacterium, fungus and/or Mycobacterium), in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012092116 | GS1 |
Customer Contacts
- Phone
- 805-960-5100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211815 | 000 |