Duns Number:251005005
Device Description: Single Drug Test Strip - 100/kit Methadone (MTD) - Cut-off 300 ng/ml
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
MTD-1S3-100
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161044,K161044
Product Code
DJC
Product Code Name
Thin Layer Chromatography, Methamphetamine
Public Device Record Key
5c64edc0-0b1f-42d6-a821-b12e70280d52
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 31, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |