Duns Number:251005005
Device Description: Rapid Response Urinalysis Reagent Strips (Microalbumin/Creatinine)
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
U2.3-1S25
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150330,K150330,K150330,K150330
Product Code
JIR
Product Code Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Public Device Record Key
236b34e4-4da4-47ff-b199-29cb54f28431
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
February 06, 2019
Package DI Number
10722066004392
Quantity per Package
24
Contains DI Package
00722066004395
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |