FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeScale Sensor
DI: 00860012092123
·
Model: LS6501
·
Affinity Biosensors, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LifeScale Sensor
- Primary DI
- 00860012092123
- Version / Model
- LS6501
- 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
- ec7dd4cc-97eb-40d7-84f8-947272483a9a
Device Description
The LifeScale Sensor is a consumable that detects organisms in the sample and measures the individual mass of each cell.
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 67586 | Antimicrobial susceptibility microfluidic resonant frequency sensor IVD | An electronic device intended to be used onboard an antimicrobial susceptibility analyser to determine the concentration and/or mass of microorganisms from a clinical specimen and/or culture isolate, for antimicrobial susceptibility profiling. The sensor is stimulated via an applied voltage to reach a resonant frequency which changes as each microorganism flows through the sensor, whereby concentration and mass parameters are calculated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012092123 | GS1 |
Customer Contacts
- Phone
- 805-960-5100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211815 | 000 |