Duns Number:126544316
Device Description: An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma.
Catalog Number
TF8146
Brand Name
Fluoro-CheckTM beta-hCG
Version/Model Number
TF8146
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
c952e5ca-5d8f-4a8d-85b1-0c79476662f6
Public Version Date
May 27, 2019
Public Version Number
3
DI Record Publish Date
April 25, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-