HardyDisk™
Basic Information
- Brand Name
- HardyDisk™
- Primary DI
- 00816576021079
- Version / Model
- Z9241
- Catalog Number
- Z9241
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- bfaec966-c63e-4ecb-b9b8-f420513bb445
Device Description
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | Microbiology | 866.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59213 | Vancomycin susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of the antimicrobial vancomycin, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816576021079 | GS1 | ||||
| Unit of Use | 00816576021819 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000509 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius