Identity
- Trade Name
- Uricult CLED/EMB FDA UDI
- Generic Name
- Multiple formulation agar culture medium IVD FDA UDI
- Device Name
- A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens. FDA UDI
- Model / Reference
- 68014 FDA UDI
- Description
- A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens. FDA UDI
Identifiers
- Catalog Number
- 1000 FDA UDI
- Primary DI / UDI-DI
- 06438115000037 FDA UDI
- FDA Product Code
- JSH FDA UDI
- GMDN Term
- Multiple formulation agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2320 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Multiple formulation agar culture medium IVD
Uricult CLED/EMB by Aidian Oy — 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
- Aidian Oy
Sources (1)
- FDA UDI befa8a91-9907-46c8-9f5a-bea36642c54d 36 fields · synced May 30, 2026