CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380175589
• Version / Model: UAREADER1
• Catalog Number: UAREADER1
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-09
• Public Version: 5
• Public Version Date: 2025-10-10
• Public Version Status: Update
• Public Device Record Key: fbce4e77-5f56-4e55-a34f-5de74bcabfe7

Device Description

Urinalysis Analyzer Kit For Urine Contains: 1 - Semi-Atuo Urine Analyzer 6 - Bottles of UA10SGL Strips X1 UAREADER1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1115	1
CEN	Dye-indicator, pH (urinary, non-quantitative)	Clinical Chemistry	862.1550	1
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE	Hematology	864.6550	2
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)	Clinical Chemistry	862.1510	1
JRE	REFRACTOMETER FOR CLINICAL USE	Clinical Chemistry	862.2800	1
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1435	1
JMA	ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)	Clinical Chemistry	862.1095	1
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1785	1
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)	Clinical Chemistry	862.1340	2
LJX	TEST, URINE LEUKOCYTE	Hematology	864.7675	1
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1645	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35918	Urine analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	No	Active
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885380175589	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity