Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Optochin/ethylhydrocupreine differentiation disc IVD FDA UDI
- Device Name
- Optochin, HardyDisk™, for the differentiation of alpha-hemolytic Streptococcus pneumoniae, 50 disks per cartridge, 1 each For use in the presumptive identification of Streptococcus pneumoniae from other alpha-hemolytic streptococci. FDA UDI
- Model / Reference
- Z7011 FDA UDI
- Description
- Optochin, HardyDisk™, for the differentiation of alpha-hemolytic Streptococcus pneumoniae, 50 disks per cartridge, 1 each For use in the presumptive identification of Streptococcus pneumoniae from other alpha-hemolytic streptococci. FDA UDI
Identifiers
- Catalog Number
- Z7011 FDA UDI
- Primary DI / UDI-DI
- 00816576028269 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Optochin/ethylhydrocupreine differentiation disc IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Optochin/ethylhydrocupreine differentiation disc IVD
HardyDisk™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optochin/ethylhydrocupreine differentiation disc IVD.
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- BD BBL™ Taxo™ P — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Taxo™ P — BECTON DICKINSON AND COMPANY · Class I
- HardyDisk™ — HARDY DIAGNOSTICS · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 16c5f48f-0be4-48bb-b876-e2303595a5ed 36 fields · synced May 30, 2026