gudid
Primary ID: 108155
AUTION EYE Sheath Solution - 10L Bottle (UDI 108155)
Manufactured by ARKRAY USA, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AUTION EYE Sheath Solution - 10L Bottle - Primary ID 108155
Device Regulatory Overview
The AUTION EYE Sheath Solution - 10L Bottle (Model/Catalog Number: 108155) is a medical device manufactured by ARKRAY USA, INC.. This product is indexed under FDA Product Code / Category Classification KQO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 108155
- Product Code / EMDN
- KQO
- Device Name
- AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed particles in urine samples through flow cell cytometry.
- Database Sync Date
- 2026-08-09 09:00:34
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of AUTION EYE Sheath Solution - 10L Bottle?
The registered manufacturer of record for AUTION EYE Sheath Solution - 10L Bottle is ARKRAY USA, INC..
What is the Primary UDI-DI identifier for AUTION EYE Sheath Solution - 10L Bottle?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 108155.
What classification code is assigned to this device?
This device is registered under product classification code KQO.
Similar Classification Devices (KQO)
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