Duns Number:227530649
Device Description: The product is required for urine samples. Urine samples must be diluted by a factor of 1 The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module.
Catalog Number
RX3950
Brand Name
ISE DIL URN
Version/Model Number
RX3950
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
K024014
Product Code
JJF
Product Code Name
Analyzer, Chemistry, Micro, For Clinical Use
Public Device Record Key
83e7347b-0844-4f35-a9cf-614f14e680b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |