FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSITITRE VIZION
DI: 00848838074509
·
Model: V2021
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SENSITITRE VIZION
- Primary DI
- 00848838074509
- Version / Model
- V2021
- 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
- 12e0c544-e117-4fb5-86a1-7372eb69557c
Device Description
The Sensititre Viin ~ isitn- ouewith. the. SensititreO. MWC or HP31 Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Senisititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Grain negative and fastidious organisms comprising of Hczemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp
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
- 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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test 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 | 00848838074509 | GS1 |