Identity
- Trade Name
- SENSITITRE VIZION FDA UDI
- Generic Name
- Antimicrobial susceptibility analyser IVD FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- V2021 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838074509 FDA UDI
- FDA Product Code
- JWY FDA UDI
- GMDN Term
- Antimicrobial susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antimicrobial susceptibility analyser IVD
Sensititre Vizion by Remel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 12e0c544-e117-4fb5-86a1-7372eb69557c 33 fields · synced May 29, 2026