Identity
- Trade Name
- VITEK® 2 AST-GP78 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-GP78 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
- 03573026554569 FDA UDI
- 510(k) Number
- K031865 FDA UDIK032766 FDA UDIK050976 FDA UDIK053097 FDA UDIK072668 FDA UDIK072695 FDA UDIK080201 FDA UDIK091126 FDA UDIK122547 FDA UDIK141149 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
Single Use
Yes
Implantable
No
Contains Latex
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-Gp78 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031865 also covers:
K032766 also covers:
K050976 also covers:
K053097 also covers:
K072668 also covers:
K072695 also covers:
K080201 also covers:
K091126 also covers:
K122547 also covers:
N50510 also covers:
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Authorization Coverage (1 country)
Regulatory Authorizations
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 80d085c2-e5e9-4bf0-a065-40c7c473792f 35 fields · synced Jun 8, 2026