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Areta Ketone Urinalysis Reagent Strips (100 tests kit）

FDA UDI

Class I (US FDA UDI)

by Easy Healthcare Corporation

Identity

Trade Name
Areta Ketone Urinalysis Reagent Strips (100 tests kit） FDA UDI
Generic Name
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Model / Reference
U031-013 FDA UDI

Identifiers

Primary DI / UDI-DI
00850253007000 FDA UDI
FDA Product Code
CDM FDA UDI
GMDN Term
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1785 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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: Urine ketone IVD, kit, rapid colorimetric, clinical

Areta Ketone Urinalysis Reagent Strips (100 tests kit） by Easy Healthcare Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine ketone IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Easy Healthcare Corporation

Sources (1)

  • FDA UDI 8591f956-e474-432f-8479-627ee5e38c9c 32 fields · synced Jun 6, 2026