Duns Number:137417965
Device Description: QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contami QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls.
Catalog Number
-
Brand Name
MEDTOXScan® QC Test Devices
Version/Model Number
833075
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
-
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
K080635,K091454,K100023
Product Code
OHQ
Product Code Name
Multi-Analyte Controls Unassayed
Public Device Record Key
cef05c5b-a459-4cdd-9fac-77109666963c
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |