HardyDisk™
- Primary DI
- 00816576021086
- Brand
- HardyDisk™
- Company
- HARDY DIAGNOSTICS
- Model
- Z9245
- Catalog number
- Z9245
- 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.
- Published
- 2016-09-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | Microbiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K000509 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816576021086 | Primary | GS1 | 0 | |
| 00816576021819 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816576021086 | 00816576021086 | 816576021086 | 0816576021086 |
| 00816576021819 | 00816576021819 | 816576021819 | 0816576021819 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | -20 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 800-266-2222 | techservice@hardydiagnostics.com |
Regulatory Flags#
- DUNS number
- 039981550
- Device count
- 250
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816576020058 | NA | E31 | E31 | 2016-09-01 |
| 00816576024995 | N/A | G123 | G123 | 2020-05-18 |
| 00816576026968 | N/A | G367 | G367 | 2024-07-08 |
| 00816576027965 | N/A | W95 | W95 | 2020-06-08 |
| 00819398028653 | N/A | Z206 | Z206 | 2020-08-06 |
| 00816576027958 | N/A | W95 | W95 | 2020-06-08 |
| 00816576024858 | N/A | G105 | G105 | 2020-05-18 |
| 00819398024600 | N/A | Y100 | Y100 | 2020-06-08 |
| 00819398024808 | N/A | Y110 | Y110 | 2020-06-09 |
| 00819398024907 | N/A | Y115 | Y115 | 2020-06-09 |
| 00819398024594 | N/A | Y100 | Y100 | 2020-06-08 |
| 00819398023610 | N/A | R76BX | R76BX | 2020-06-05 |
| 00819398024242 | HardyFlask™ | X26 | X26 | 2020-06-08 |
| 00819398025102 | N/A | Y130 | Y130 | 2020-06-09 |
| 00819398023603 | N/A | R76BX | R76BX | 2020-06-05 |
| 00819398024235 | HardyFlask™ | X26 | X26 | 2020-06-08 |
| 00819398022118 | N/A | L22 | L22 | 2020-06-03 |
| 00819398025560 | N/A | Y310 | Y310 | 2020-06-09 |
| 00819398028264 | N/A | MV1 | MV1 | 2020-06-04 |
| 00816576027194 | HardyDisk™ | Z9495 | Z9495 | 2025-08-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05032384550784 | Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10 | OXOID LIMITED | JTN | 2026-01-21 |
| 05032384533121 | Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50 | OXOID LIMITED | JTN | 2025-12-12 |
| 00816576027194 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-08-08 |
| 00816576027200 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-08-08 |
| 00816576027088 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-08-08 |
| 00816576027057 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-07-18 |
| 00816576027071 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-07-14 |
| 00816576026975 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2025-07-14 |
| 05032384516018 | Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | JTN | 2024-10-28 |
| 05032384537723 | Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di | OXOID LIMITED | JTN | 2024-10-28 |
| 05032384580231 | Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | JTN | 2024-10-28 |
| 05032384579945 | Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di | OXOID LIMITED | JTN | 2024-10-28 |
| 05032384526123 | Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | JTN | 2024-10-01 |
| 05032384088423 | Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | JTN | 2024-07-05 |
| 05032384574964 | Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs | OXOID LIMITED | JTN | 2024-07-05 |
| 00819398020732 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-11-21 |
| 00819398020923 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-11-21 |
| 00819398020725 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-11-21 |
| 00819398021197 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-09-08 |
| 00819398021548 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-09-08 |
| 00819398021180 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2023-09-08 |
| 00382902322559 | BD BBL™ Sensi-Disc™ Cefiderocol 30 µg | BECTON, DICKINSON AND COMPANY | JTN | 2023-06-16 |
| 05032384526116 | NA | OXOID LIMITED | JTN | 2021-12-07 |
| 00816576028283 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-08-07 |
| 00816576028306 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-08-07 |
| 00816576028290 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-08-07 |
| 00819398028103 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-03-03 |
| 00819398028110 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-03-03 |
| 00819398028097 | HardyDisk™ | HARDY DIAGNOSTICS | JTN | 2020-03-03 |
| 05032384140480 | Oxoid™ Moxifloxacin Antimicrobial Susceptibility Disks | OXOID LIMITED | JTN | 2020-01-30 |