Duns Number:051624070
Device Description: Lyphochek Quantitative Urine Control Bilevel MiniPak (A human urine assayed chemistry cont Lyphochek Quantitative Urine Control Bilevel MiniPak (A human urine assayed chemistry control.)
Catalog Number
375X
Brand Name
Lyphochek
Version/Model Number
375X
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
K880495,K880496
Product Code
JJW
Product Code Name
Urinalysis controls (assayed and unassayed)
Public Device Record Key
0831761e-87bb-473b-8f80-9b9a36892a49
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 |