Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 00722066004388
• Version / Model: U2.3-1S25
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-02-06
• Public Version: 5
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 236b34e4-4da4-47ff-b199-29cb54f28431

Device Description

Rapid Response Urinalysis Reagent Strips (Microalbumin/Creatinine)

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
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	862.1645	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60471	Microalbumin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of microalbumin in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect small amounts of albumin in the urine, moderately increased albuminuria or microalbuminuria, which indicate kidney disease. 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	00722066004388	GS1
Unit of Use	00722066004418	GS1