Accustrip URS Strips + Reader

Basic Information

• Brand Name: Accustrip URS Strips + Reader
• Primary DI: 20763924897104
• Version / Model: UA897
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 9
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: f0907d67-92ec-4cbe-afea-d17386dffbfd

Device Description

Accustrip URS 10 parameter Strips and Accustrip URS Reader

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRE	Refractometer For Clinical Use	Clinical Chemistry	862.2800	1
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	862.1785	1
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	862.1645	1
CEN	Dye-Indicator, Ph (Urinary, Non-Quant.)	Clinical Chemistry	862.1550	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	862.1340	2
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	862.1115	1
LJX	Test, Urine Leukocyte	Hematology	864.7675	1
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43539	Urine catalase IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase 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. 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	20763924897104	GS1
Unit of Use	10763924897107	GS1

Premarket Submissions

Submission Number	Supplement Number
K061742	000
K991927	000