Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 00722066003640
• Version / Model: U2.3-1S25
• Catalog Number: U2.3-1S25
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-10-17
• Public Version: 9
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 1172a376-bdb5-4200-853c-bda5419bf5b3
• Distribution End Date: 2023-07-12

Device Description

Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative determination of Albumin and Creatinine in urine.

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
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	862.1225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54517	Urine creatinine 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 creatinine 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
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	00722066003640	GS1
Unit of Use	00722066003749	GS1

Premarket Submissions

Submission Number	Supplement Number
K061419	000