SENSITITRE VIZION
- Primary DI
- 00848838074509
- Brand
- SENSITITRE VIZION
- Company
- REMEL, INC.
- Model
- V2021
- 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
- Published
- 2023-06-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00848838074509 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00848838074509 | 00848838074509 | 848838074509 | 0848838074509 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 065769564
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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