AUTION EYE™ Sheath Solution - 10L Bottle

FDA UDI

Class I (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: AUTION EYE™ Sheath Solution - 10L Bottle FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
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. FDA UDI
Model / Reference: 108155 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482181550 FDA UDI
510(k) Number: K232416 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine analyser IVD, laboratory

AUTION EYE™ Sheath Solution - 10L Bottle 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

K232416 also covers:

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 4df69f15-0cec-457b-a836-99fc5615c2fb 36 fields · synced May 30, 2026