Duns Number:296822794
Device Description: IMMULITE 2000 Crotisol Kit Domestic 600T
Catalog Number
L2KCO6(D)
Brand Name
IMMULITE 2000 Crotisol Kit Domestic 600T
Version/Model Number
10901845
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202826,K931409
Product Code
CGR
Product Code Name
RADIOIMMUNOASSAY, CORTISOL
Public Device Record Key
419a764a-f9bd-4a1c-9521-90202618024a
Public Version Date
November 18, 2021
Public Version Number
7
DI Record Publish Date
January 15, 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 | 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 |