Duns Number:959103565
Device Description: 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control
Catalog Number
25000080
Brand Name
FastPack® IP SHBG
Version/Model Number
FastPack® IP SHBG 60 Immunoassay
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
K182521,K182521
Product Code
CDZ
Product Code Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Public Device Record Key
da0f27c5-9989-4fa5-b815-37ac62c810b8
Public Version Date
March 12, 2019
Public Version Number
2
DI Record Publish Date
February 01, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |