Duns Number:687910463
Device Description: It is used for the quantitative measurement of Total Testosterone in human serum or hepari It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample.
Catalog Number
FRTEAP 020
Brand Name
FREND
Version/Model Number
FRTE-AP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153577
Product Code
CDZ
Product Code Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Public Device Record Key
26ed69ee-1a18-4940-873a-9acdb3f9a2da
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 04, 2018
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |