AccessGUDID - DEVICE: Rapid Response (00722066003640)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: U2.3-1S25
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: U2.3-1S25
Company Name: BTNX Inc

Primary DI Number: 00722066003640
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2023
Device Count: 25
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JFY	Enzymatic Method, Creatinine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061419	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1172a376-bdb5-4200-853c-bda5419bf5b3
Public Version Date: July 13, 2023
Public Version Number: 9
DI Record Publish Date: October 17, 2016