Duns Number:227530649
Catalog Number
-
Brand Name
LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)
Version/Model Number
LUN5048
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
-
Product Code
OHQ
Product Code Name
Multi-Analyte Controls Unassayed
Public Device Record Key
86aeb419-8277-4fa5-b059-d243692bcca7
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
June 03, 2019
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 | 305 |
2 | A medical device with a moderate to high risk that requires special controls. | 258 |