Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Sodium polyanethol sulfonate (SPS) differentiation disc IVD FDA UDI
- Device Name
- SPS Disks, 1mg, 1 x 50 disks, for identification of Gardnerella vaginalis and P. anaerobius HardyDisk™ SPS Identification Disks evaluate the ability of an organism to grow in the presence of Sodium Polyanethol Sulfonate. HardyDisk™ SPS Identification Disks can be used to presumptively identify microorganisms including but not limited to Peptostreptococcus anaerobius, Gardnerella vaginalis, and Haemophilus ducreyi. FDA UDI
- Model / Reference
- Z7381 FDA UDI
- Description
- SPS Disks, 1mg, 1 x 50 disks, for identification of Gardnerella vaginalis and P. anaerobius HardyDisk™ SPS Identification Disks evaluate the ability of an organism to grow in the presence of Sodium Polyanethol Sulfonate. HardyDisk™ SPS Identification Disks can be used to presumptively identify microorganisms including but not limited to Peptostreptococcus anaerobius, Gardnerella vaginalis, and Haemophilus ducreyi. FDA UDI
Identifiers
- Catalog Number
- Z7381 FDA UDI
- Primary DI / UDI-DI
- 00816576028856 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Sodium polyanethol sulfonate (SPS) 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: Sodium polyanethol sulfonate (SPS) differentiation disc IVD
HardyDisk™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sodium polyanethol sulfonate (SPS) differentiation disc IVD.
- BD BBL™ Taxo™ SPS — BECTON DICKINSON AND COMPANY · 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 dfd70333-6c0b-4add-afdc-ae8107b15385 36 fields · synced Jun 6, 2026