Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- The UniSystem tubes are disposable, polystyrene tubes graduated to 12 mL, with unique patented tips designed to retain a standardized 0.4 mL volume of sediment or liquid when decanted. Up to 10 tubes can be simultaneously decanted by using the UniSystem Rack or tubes can be individually decanted by hand. FDA UDI
- Model / Reference
- UniSystem Collection Pack FDA UDI
- Description
- The UniSystem tubes are disposable, polystyrene tubes graduated to 12 mL, with unique patented tips designed to retain a standardized 0.4 mL volume of sediment or liquid when decanted. Up to 10 tubes can be simultaneously decanted by using the UniSystem Rack or tubes can be individually decanted by hand. FDA UDI
Identifiers
- Catalog Number
- 200202 FDA UDI
- Primary DI / UDI-DI
- 00673693220118 FDA UDI
- FDA Product Code
- IFB FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3300 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
Yes
FDA UDI
Category: Urine specimen collection kit IVD
Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI 86e4f512-5e24-4edd-ba65-f3c000ddc5dc 34 fields · synced Jun 8, 2026