Duns Number:189222334
Device Description: HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in h HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in head hair with a cutoff of 500 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 (Opiates)
Version/Model Number
K042725
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 12, 2021
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
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
7cfe9435-b253-419d-ba3b-ddb9c2fd81e1
Public Version Date
March 24, 2022
Public Version Number
4
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 |