Duns Number:010551716
Device Description: OPI300/THC50/AMP1000/MET1000/BZO300 Adulteration Screen for CR-NI-PH-OX
Catalog Number
QT16A
Brand Name
QuickTox Drug Screen Dipcard
Version/Model Number
QT16A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2018
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
K022355
Product Code
DJC
Product Code Name
Thin Layer Chromatography, Methamphetamine
Public Device Record Key
cf7d14d0-b1f0-45b2-b0cd-83607c4b9661
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
March 31, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |
| U | Unclassified | 1 |