Duns Number:144968104
Device Description: Phosphorus Liquid Reagent (2 x 125 mL)
Catalog Number
PHO2-125
Brand Name
JAS Diagnostics
Version/Model Number
PHO2-125
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
-
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
K003912
Product Code
CEO
Product Code Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Public Device Record Key
4b37a0da-5bbb-4def-9fa2-0524cc23971b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 04, 2017
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 | 85 |
2 | A medical device with a moderate to high risk that requires special controls. | 163 |