DG Health

GUDID 00023513487441

OTC Single Use urinary test strip

REESE PHARMACEUTICAL COMPANY

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid
Primary Device ID00023513487441
NIH Device Record Keyf544fa20-aa9a-45a7-9991-c53f6b64ef13
Commercial Distribution StatusIn Commercial Distribution
Brand NameDG Health
Version Model NumberUTES
Company DUNS004172052
Company NameREESE PHARMACEUTICAL COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com
Phone216-231-6441
Emailjake.blake@reesechemical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100023513487441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJXTest, Urine Leukocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-12-22
Device Publish Date2020-06-01

Devices Manufactured by REESE PHARMACEUTICAL COMPANY

10023513132157 - Reese's ColoTest2024-05-06
10023513132140 - Reese's ColoTest2024-01-31
00023513487441 - DG Health2021-12-22OTC Single Use urinary test strip
00023513487441 - DG Health2021-12-22 OTC Single Use urinary test strip
00023513000039 - TopCare2020-08-24 OTC Single Use urinary test strip

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