Duns Number:605151018
Device Description: Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in pe Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.
Catalog Number
5122
Brand Name
Serim® PeriScreen™ Test Strips
Version/Model Number
5122
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000578,K000578
Product Code
LJX
Product Code Name
Test, Urine Leukocyte
Public Device Record Key
b2820dbd-6d26-4679-ad2d-0a8b23da23ed
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-