Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Bacitracin differentiation disc IVD FDA UDI
- Device Name
- Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcus pyogenes), 50 disks per cartridge, 1 cart., not for antimicrobial sensitivity tests, Used in the presumptive identification of group A, beta-hemolytic streptococci. The test differentiates group A streptococci from other Lancefield groups of hemolytic streptococci by inhibiting the growth of group A streptococci around a disk containing approximately 0.04 units bacitracin. FDA UDI
- Model / Reference
- Z7021 FDA UDI
- Description
- Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcus pyogenes), 50 disks per cartridge, 1 cart., not for antimicrobial sensitivity tests, Used in the presumptive identification of group A, beta-hemolytic streptococci. The test differentiates group A streptococci from other Lancefield groups of hemolytic streptococci by inhibiting the growth of group A streptococci around a disk containing approximately 0.04 units bacitracin. FDA UDI
Identifiers
- Catalog Number
- Z7021 FDA UDI
- Primary DI / UDI-DI
- 00816576028283 FDA UDI
- 510(k) Number
- K011086 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Bacitracin differentiation 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
No
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: Bacitracin differentiation disc IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bacitracin differentiation disc IVD.
- BD BBL™ Taxo™ A — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Taxo™ A — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Taxo™ A — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Taxo™ A — BECTON DICKINSON AND COMPANY · Class I
- HardyDisk™ — HARDY DIAGNOSTICS · Class II
- HardyDisk™ — HARDY DIAGNOSTICS · Class II
Cleared under the same submission
K011086 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 fdeee4f8-ce61-4e78-a3dc-2140f181ae82 37 fields · synced May 30, 2026