Duns Number:078742335
Device Description: CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV- CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays.
Catalog Number
-
Brand Name
LiquidQC CoV-2 IgG Control
Version/Model Number
91494
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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
-
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
817fc778-bba2-4327-b5a9-201abb1f5fc6
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |