Identity
- Trade Name
- HairCheck-DT (Amphetamines) FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection of amphetamines 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. FDA UDI
- Model / Reference
- K051161 FDA UDI
- Description
- HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection of amphetamines 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868586000230 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HairCheck-DT (Amphetamines) is a comprehensive, enzyme immunoassay-based test kit for the qualitative detection of amphetamines in head hair. Developed and manufactured by Quest Diagnostics, this device provides accurate results and is an essential tool for clinical laboratories seeking to identify and monitor amphetamine exposure.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quest Diagnostics
Sources (1)
- FDA UDI aeecb348-73f2-4265-99ce-ae07c97e0517 34 fields · synced Jul 2, 2026