Duns Number:605151018
Device Description: The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the p The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
Catalog Number
05140K
Brand Name
Serim® PyloriTek® Test Kit
Version/Model Number
05140K
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
K953632,K953632,K953632,K953632
Product Code
LYR
Product Code Name
Helicobacter Pylori
Public Device Record Key
b3f89921-9db5-4b95-bfa5-a0baba6fd881
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
M1745140K2
Quantity per Package
1
Contains DI Package
M1745140K1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit