Duns Number:051624070
Device Description: Lyphochek Therapeutic Drug Monitoring Control (TDM), Level 2 (A human serum assayed TDM co Lyphochek Therapeutic Drug Monitoring Control (TDM), Level 2 (A human serum assayed TDM control.)
Catalog Number
452
Brand Name
Lyphochek
Version/Model Number
452
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
K880145
Product Code
DIF
Product Code Name
Drug mixture control materials
Public Device Record Key
feacd2aa-3b40-4bd3-b6c8-35c67fb17ae4
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |