← Back to catalogue

DG Health

FDA UDI

Class I (US FDA UDI)

by Reese Pharmaceutical Company

Identity

Trade Name
DG Health FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
OTC Single Use urinary test strip FDA UDI
Model / Reference
UTES FDA UDI
Description
OTC Single Use urinary test strip FDA UDI

Identifiers

Primary DI / UDI-DI
00023513487441 FDA UDI
510(k) Number
K063295 FDA UDI
FDA Product Code
LJX FDA UDI
JMT FDA UDI
GMDN Term
Multiple urine analyte 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

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: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

DG Health by Reese Pharmaceutical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K063295 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Reese Pharmaceutical Company

Sources (1)

  • FDA UDI f544fa20-aa9a-45a7-9991-c53f6b64ef13 35 fields · synced Jun 8, 2026