Identity
- Trade Name
- VITEK® 2 AST-XN31 EUDAMEDFDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- VITEK® 2 AST-XN31 EUDAMEDVITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
- Model / Reference
- 543421 EUDAMEDVITEK® 2 AST-XN31 FDA UDI
- Description
- VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026635459 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI002152TG EUDAMED
- 510(k) Number
- K121546 FDA UDIK161437 FDA UDIK161510 FDA UDIK163006 FDA UDIK163563 FDA UDIK172731 FDA UDIK183360 FDA UDIK183415 FDA UDIK183551 FDA UDIK191766 FDA UDIK193567 FDA UDIK193572 FDA UDI
- FDA Product Code
- LON FDA UDI
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
- GMDN Term
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-microorganism antimicrobial susceptibility culture medium IVD
Vitek® 2 Ast-Xn31 by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K121546 also covers:
K161437 also covers:
K161510 also covers:
- VITEK® 2 AST-N801 — BIOMERIEUX , INC.
- VITEK® 2 AST-N804 — BIOMERIEUX , INC.
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K163006 also covers:
K163563 also covers:
- VITEK® 2 AST-N800 — BIOMERIEUX , INC.
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- VITEK® 2 AST-N802 — BIOMERIEUX , INC.
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K172731 also covers:
- VITEK® 2 AST-N801 — BIOMERIEUX , INC.
- VITEK® 2 AST-N802 — BIOMERIEUX , INC.
- VITEK® 2 AST-N804 — BIOMERIEUX , INC.
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- VITEK® 2 AST-N813 — BIOMERIEUX , INC.
- VITEK® 2 AST-XN30 — BIOMERIEUX , INC.
- VITEK® 2 AST-XN33 — BIOMERIEUX , INC.
K183360 also covers:
K183415 also covers:
K183551 also covers:
K191766 also covers:
K193567 also covers:
K193572 also covers:
N50510 also covers:
- SALINE SOLUTION — BIOMERIEUX , INC.
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- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN75 — BIOMERIEUX , INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 9bf669f7-9bb5-433b-98af-fc16b24ea163 35 fields · synced Jul 9, 2026
- EUDAMED 722dafc0-0fbb-4bd2-9ff5-5b7e892b2292 61 fields · synced Jul 9, 2026