Identity
- Trade Name
- Aution™ AU Control Solution FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) FDA UDI
- Model / Reference
- 73806 FDA UDI
- Description
- Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987486738060 FDA UDI
- 510(k) Number
- K121456 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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: Multiple urine analyte IVD, control
Aution™ AU Control Solution by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple urine analyte IVD, control.
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- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
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Cleared under the same submission
K121456 also covers:
- AUTION™ Diluent BAC — ARKRAY USA, INC.
- AUTION™ Diluent SED — 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™ 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 6cb96b1a-b9f6-429b-bebc-ebcada002a0e 36 fields · synced May 30, 2026