Duns Number:315028860
Device Description: Testosterone G2 Elecsys E2G 300 V2
Catalog Number
08946370190
Brand Name
Elecsys Testosterone II
Version/Model Number
08946370190
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
-
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
K211685
Product Code
CDZ
Product Code Name
RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
Public Device Record Key
75db47c8-5d77-4d0e-b1c3-2d15dc0d1a39
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 21, 2022
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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |