Identity
- Trade Name
- VITEK® 2 AST-YS05 FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents FDA UDI
- Model / Reference
- VITEK® 2 AST-YS05 FDA UDI
- Description
- The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026529758 FDA UDI
- FDA Product Code
- NGZ FDA UDI
- GMDN Term
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vitek® 2 Ast-Ys05 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092454 also covers:
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 2aee0d89-b816-494c-bfa3-ded8a0d64058 36 fields · synced Jun 1, 2026