Duns Number:106712748
Catalog Number
-
Brand Name
Deltec
Version/Model Number
21-2895-01
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
K951078,K951078
Product Code
JLS
Product Code Name
RADIOIMMUNOASSAY, PROGESTERONE
Public Device Record Key
9e1ef8c8-b1bf-418e-b08c-299cd3c75bd8
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
30610586016435
Quantity per Package
12
Contains DI Package
00610586016434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |