Identity
- Trade Name
- AUTION™ Diluent SED FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. FDA UDI
- Model / Reference
- 73807 FDA UDI
- Description
- Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987486738077 FDA UDI
- 510(k) Number
- K121456 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
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
Category: Urine analyser IVD, laboratory
AUTION™ Diluent SED by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121456 also covers:
- AUTION™ Diluent BAC — ARKRAY USA, INC.
- AUTION™ Sheath Solution — ARKRAY USA, INC.
- AUTION™ Staining Solution BAC — ARKRAY USA, INC.
- AUTION™ Staining Solution SED — ARKRAY USA, INC.
- AUTION™ Uriflet 9HA Test Strips — ARKRAY USA, INC.
- Aution™ AU Control Solution — ARKRAY USA, INC.
- Aution™ Hybrid AU-4050 Chemical Analyzer — ARKRAY USA, 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
- Arkray Usa, Inc.
Sources (1)
- FDA UDI 5d2d166b-21e0-4ffc-b31f-d0acebcc892c 36 fields · synced Jun 7, 2026