Duns Number:020335667
Device Description: Exton Qualitative Reagent, for the Qualitative Detection of Albumin in Urine
Catalog Number
2950
Brand Name
Ricca Chemical Company®
Version/Model Number
2950-32
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIQ
Product Code Name
TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
Public Device Record Key
f4ad89bd-b3c7-4e6c-acef-c4063e4a172b
Public Version Date
February 12, 2021
Public Version Number
1
DI Record Publish Date
February 04, 2021
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 | 23 |