Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Antibacterial susceptibility testing disc IVD FDA UDI
- Device Name
- Sulbactam / Durlobactam 10 /10 µg (SUD20), 1 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer) of rapidly growing and certain fastidious bacterial pathogens when there is the need to determine the susceptibility of microorganisms to Sulbactam / Durlobactam. Product can be used to determine the zone diameter (mm) of Sulbactam / Durlobactam against the following microorganisms for which Sulbactam / Durlobactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC). FDA UDI
- Model / Reference
- Z9461 FDA UDI
- Description
- Sulbactam / Durlobactam 10 /10 µg (SUD20), 1 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer) of rapidly growing and certain fastidious bacterial pathogens when there is the need to determine the susceptibility of microorganisms to Sulbactam / Durlobactam. Product can be used to determine the zone diameter (mm) of Sulbactam / Durlobactam against the following microorganisms for which Sulbactam / Durlobactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC). FDA UDI
Identifiers
- Catalog Number
- Z9461 FDA UDI
- Primary DI / UDI-DI
- 00819398020732 FDA UDI
- 510(k) Number
- K231568 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Antibacterial susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 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: Antibacterial susceptibility testing disc IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231568 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
- Hardy Diagnostics
Sources (1)
- FDA UDI 3b3773a0-16a7-4b50-a866-a20030c8eebe 37 fields · synced May 30, 2026