AUTION™ Sticks 10EA Test Strips

FDA UDI

Class I (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: AUTION™ Sticks 10EA Test Strips FDA UDI
Generic Name: Urine analyser IVD, laboratory, semi-automated FDA UDI
Device Name: Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. FDA UDI
Model / Reference: 73526 FDA UDI
Description: Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482735265 FDA UDI
510(k) Number: K160062 FDA UDI
FDA Product Code: CDM FDA UDI
JRE FDA UDI
JIO FDA UDI
JMT FDA UDI
JJB FDA UDI
LJX FDA UDI
JIL FDA UDI
KQO FDA UDI
CEN FDA UDI
JIR FDA UDI
JIN FDA UDI
GMDN Term: Urine analyser IVD, laboratory, semi-automated FDA UDI

Classification

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

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, semi-automated

AUTION™ Sticks 10EA Test Strips 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™ MAX AX-4022 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 7b676fcc-441b-4923-a0ae-acb206271d9f 36 fields · synced Jun 8, 2026