Duns Number:227530649
Device Description: This product is intended for in vitro diagnostic use, in the quality control of diagnostic This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
Catalog Number
-
Brand Name
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL
Version/Model Number
LAE4215
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
560bcb80-0cd9-4168-a42d-70d181242e24
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
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 |