One+Step 10A

Basic Information

• Brand Name: One+Step 10A
• Primary DI: 08806141303497
• Version / Model: 30D4
• Company Name: DFI CO.,LTD
• Labeler DUNS: 688779180
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-16
• Public Version: 1
• Public Version Date: 2023-10-24
• Public Version Status: New
• Public Device Record Key: ee216bc5-512b-4dcc-83bf-7360a40b6deb
• Distribution End Date: 2023-10-16

Device Description

One device is included 100 test strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LJX	Test, Urine Leukocyte	Hematology	864.7675	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	862.1785	1
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	862.1115	1
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	862.1645	1
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	862.1095	1
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	862.1550	1
JRE	Refractometer For Clinical Use	Clinical Chemistry	862.2800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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	08806141303497	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius