Identity
- Trade Name
- VITEK® 2 AST-GN83 FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
- Model / Reference
- VITEK® 2 AST-GN83 FDA UDI
- Description
- VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026531065 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Commercial Distribution
- 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
Category: General-microorganism antimicrobial susceptibility culture medium IVD
Vitek® 2 Ast-Gn83 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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K110106 also covers:
- VITEK® 2 AST-GN48 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN66 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN67 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN68 — BIOMERIEUX , INC.
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- VITEK® 2 AST-GN73 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN75 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN76 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN77 — BIOMERIEUX , INC.
K113200 also covers:
- VITEK® 2 AST-GN66 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN67 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN68 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN69 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN70 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN72 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN73 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN76 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN77 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN79 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN80 — BIOMERIEUX , INC.
N50510 also covers:
- SALINE SOLUTION — BIOMERIEUX , INC.
- SMART CARRIER STATION — BIOMERIEUX , INC.
- VITEK — BIOMERIEUX , INC.
- VITEK® 2 AST-GN48 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN66 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN68 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN69 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN70 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN72 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN73 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN75 — BIOMERIEUX , INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI c7d2039e-85b1-45e1-85e5-b93f97415a81 35 fields · synced May 31, 2026