AUTION™ MAX AX-4022 Analyzer

FDA UDI

Class I (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: AUTION™ MAX AX-4022 Analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory, semi-automated FDA UDI
Device Name: Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. FDA UDI
Model / Reference: 102974 FDA UDI
Description: Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482129743 FDA UDI
510(k) Number: K160062 FDA UDI
FDA Product Code: JMT FDA UDI
JIN FDA UDI
JRE FDA UDI
JIR FDA UDI
JJB FDA UDI
JIO FDA UDI
KQO FDA UDI
CEN FDA UDI
CDM FDA UDI
JIL FDA UDI
LJX FDA UDI
GMDN Term: Urine analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1510 FDA UDI
862.1435 FDA UDI
862.2800 FDA UDI
862.1645 FDA UDI
862.1115 FDA UDI
864.6550 FDA UDI
862.2900 FDA UDI
862.1550 FDA UDI
862.1785 FDA UDI
862.1340 FDA UDI
864.7675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Urine analyser IVD, laboratory, semi-automated

AUTION™ MAX AX-4022 Analyzer 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

K160062 also covers:

AUTION™ Sticks 10EA Test Strips — 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 d5aeb679-7a4a-4156-a083-276cb8310d43 35 fields · synced May 31, 2026