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HealthyMe UTI Urinary Tract Infection Test Strips

FDA UDI

Class I (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
HealthyMe UTI Urinary Tract Infection Test Strips FDA UDI
Generic Name
Urine leukocyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urinary Tract Infection home test FDA UDI
Model / Reference
765100 FDA UDI
Description
Urinary Tract Infection home test FDA UDI

Identifiers

Primary DI / UDI-DI
00682607651009 FDA UDI
FDA Product Code
LJX FDA UDI
JMT FDA UDI
GMDN Term
Urine leukocyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.7675 FDA UDI
862.1510 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

No

FDA UDI

Over-the-Counter

Yes

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 nitrite IVD, kit, rapid colorimetric, clinicalUrine leukocyte IVD, kit, rapid colorimetric, clinical

HealthyMe UTI Urinary Tract Infection Test Strips by ACON Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI 7a576b5b-d180-4e00-ac9b-8ad5aace663c 35 fields · synced Jun 9, 2026