Identity
- Trade Name
- KOVA FDA UDI
- Generic Name
- Urine sediment IVD, control FDA UDI
- Device Name
- 2x12mL International FDA UDI
- Model / Reference
- 87222E FDA UDI
- Description
- 2x12mL International FDA UDI
Identifiers
- Catalog Number
- 87222E FDA UDI
- Primary DI / UDI-DI
- 00855617006453 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Urine sediment IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- Not 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
Kova by Kova International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kova International Inc
Sources (1)
- FDA UDI 91942ac7-609b-4410-8930-d9bd8aea0ba1 37 fields · synced Jun 8, 2026