Identity
- Trade Name
- Siemens FDA UDI
- Generic Name
- Urine sediment IVD, control FDA UDI
- Device Name
- Liquid QC Kit + Sediment FDA UDI
- Model / Reference
- 11561696 FDA UDI
- Description
- Liquid QC Kit + Sediment FDA UDI
Identifiers
- Catalog Number
- 11561696 FDA UDI
- Primary DI / UDI-DI
- 00850015517198 FDA UDI
- 510(k) Number
- K843565 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
No
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
Siemens by Kova International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K843565 also covers:
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
- KOVA — KOVA INTERNATIONAL INC
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 313eba78-f329-4b5d-ab55-d69629fe27fa 37 fields · synced Jun 1, 2026