Duns Number:790175165
Device Description: Immunoassay for the detection of methamphetamine in human urine
Catalog Number
07RD7005
Brand Name
QuickProfile™ Methamphetamine Test Strip
Version/Model Number
07RD7005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
DJC
Product Code Name
Thin Layer Chromatography, Methamphetamine
Public Device Record Key
bcca2646-b23e-4932-837e-aa9cde42f078
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 15, 2017
Package DI Number
M90107RD70051
Quantity per Package
50
Contains DI Package
M90107RD70050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 117 |
U | Unclassified | 2 |