Identity
- Trade Name
- VITEK® 2 AST-GP72 FDA UDI
- Generic Name
- General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae FDA UDI
- Model / Reference
- VITEK® 2 AST-GP72 FDA UDI
- Description
- VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026530662 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-Gp72 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.
- VITEK® 2 AST-N416 — Biomérieux · Class B
- REMEL — REMEL, INC. · Class I
- VITEK® 2 AST-N457 — Biomérieux · Class B
- REMEL — REMEL, INC. · Class I
- REMEL — REMEL, INC. · Class I
- MicroScan — Beckman Coulter, Inc. · Class I
- MicroScan — Beckman Coulter, Inc. · Class I
- MicroScan — Beckman Coulter, Inc. · Class I
Cleared under the same submission
K032738 also covers:
K032766 also covers:
K072668 also covers:
K072695 also covers:
K091126 also covers:
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 c7b00af4-783d-42ed-95ff-dc3d5a2b4345 35 fields · synced Jun 8, 2026