Duns Number:296822794
Device Description: Progesterone Sample Diluent - IMMULITE - CAL - 1x25mL
Catalog Number
LPWZ
Brand Name
IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent
Version/Model Number
10388207
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JLS
Product Code Name
RADIOIMMUNOASSAY, PROGESTERONE
Public Device Record Key
6d8a6185-2b5a-43fe-92c3-34511ad08c55
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 | 143 |
2 | A medical device with a moderate to high risk that requires special controls. | 493 |
3 | A medical device with high risk that requires premarket approval | 22 |