FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeScale AST
DI: 00860012092109
·
Model: 3010-0000
·
Affinity Biosensors, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LifeScale AST
- Primary DI
- 00860012092109
- Version / Model
- 3010-0000
- 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
- 58c62e63-129e-4e35-bf37-37b3b04ce3b2
Device Description
LifeScale AST is a semi-automated instrument system for antimicrobial susceptibility testing (AST) directly from positive blood cultures for which the Gram stain shows gram-negative bacilli.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | Microbiology | 866.1650 | 2 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00860012092109 | GS1 |
Customer Contacts
- Phone
- 805-960-5100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211815 | 000 |