Duns Number:051624070
Device Description: Lyphochek Urine Toxicology Control MiniPak (A human urine drugs of abuse control)
Catalog Number
470X
Brand Name
Lyphochek
Version/Model Number
470X
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
K881989
Product Code
DIF
Product Code Name
Drug mixture control materials
Public Device Record Key
a429530b-579d-41c3-a677-881d92c480f0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2017
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 |