THE SENSITITRE AIM
Basic Information
- Brand Name
- THE SENSITITRE AIM
- Primary DI
- 00848838097409
- Version / Model
- V3020
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- d989653e-ec29-4c68-a6d2-931ab436d08d
Device Description
The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate. The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle. The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LIE | Reagent/Device, Inoculum Calibration | Microbiology | 866.1640 | 2 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 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 |
|---|---|---|---|---|---|---|
| Primary | 00848838097409 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103456 | 000 |