Identity
- Trade Name
- UA Win10 Kit FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- Urinalysis Win10 Kit with PC7 hardware FDA UDI
- Model / Reference
- C52900 FDA UDI
- Description
- Urinalysis Win10 Kit with PC7 hardware FDA UDI
Identifiers
- Catalog Number
- C52900 FDA UDI
- Primary DI / UDI-DI
- 15099590735982 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, laboratory
UA Win10 Kit by Beckman Coulter Ireland Inc. — 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
- Beckman Coulter Ireland Inc.
Sources (1)
- FDA UDI c1ee39b1-9547-47e9-b04a-52243b9f8e14 34 fields · synced May 30, 2026