Duns Number:189222334
Device Description: HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in h HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Catalog Number
-
Brand Name
HairCheck-DT (Cocaine)
Version/Model Number
K023626
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 13, 2017
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
-
Product Code
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
7cc1b734-46dc-4436-a0c4-d818059ef3c4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |
| U | Unclassified | 1 |