Duns Number:296822794
Device Description: Pyrilinks-D - IMMULITE - CTL - 2x2mL
Catalog Number
LPDCM
Brand Name
IMMULITE® Systems PDP CONTROL Pyrilinks-D
Version/Model Number
10385243
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
K980833
Product Code
JMM
Product Code Name
COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE
Public Device Record Key
428b4626-2503-4c43-bbb9-18e1b3cbf99b
Public Version Date
April 29, 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 | 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 |