Detector UA 2

Basic Information

• Brand Name: Detector UA 2
• Primary DI: 10722355002245
• Version / Model: IDU-2PG
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-25
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 17bdf112-a948-4e2c-b07e-89a2e984ab6a

Device Description

Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1645	1
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)	Clinical Chemistry	862.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54518	Urine glucose 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 glucose 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 aid clinicians in the diagnosis and monitoring of diabetes. It is not intended to be used for self-testing.	No	Active
54523	Urine protein 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 protein 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
Package	20722355002181	GS1		12	In Commercial Distribution
Primary	10722355002245	GS1
Unit of Use	80722355002244	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955438	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius