Mission Urinalysis Reagent Strips

Basic Information

• Brand Name: Mission Urinalysis Reagent Strips
• Primary DI: 00682607000616
• Version / Model: U031-071
• Company Name: ACON LABORATORIES, INC.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ecd23a92-b5cd-4c1b-aceb-ae39f2b87310

Device Description

Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE	Hematology	864.6550	2
LJX	TEST, URINE LEUKOCYTE	Hematology	864.7675	1
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)	Clinical Chemistry	862.1550	1
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1645	1
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)	Clinical Chemistry	862.1510	1
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)	Clinical Chemistry	862.1340	2
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1435	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	00682607000616	GS1
Unit of Use	00682607000975	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit