Duns Number:388240673
Device Description: For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Catalog Number
L2KPM
Brand Name
IMMULITE 2000/XPi Probe Cleaning Kit
Version/Model Number
10385229
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
K905215
Product Code
JJQ
Product Code Name
COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE
Public Device Record Key
82d9703b-bf04-4452-b95c-72e6683b72b5
Public Version Date
April 07, 2022
Public Version Number
3
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |