Identity
- Trade Name
- HairCheck-DT (THC) Exempt FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls. FDA UDI
- Model / Reference
- PVJ-Exempt FDA UDI
- Description
- HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 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
- 00868586000261 FDA UDI
- FDA Product Code
- PVJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
HairCheck-DT (THC) Exempt by Quest Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA).
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- Syva® Emit® II Plus Cannabinoid Assay — Siemens Healthcare Diagnostics · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® THC RGT KIT Product No. DT410 — Carolina Liquid Chemistries Corp. · Class II
- Atellica CH Thc — Siemens Healthcare Diagnostics · Class II
- Pointe Cannabinoid (THC) Reagent Set — POINTE SCIENTIFIC, INC. · Class II
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 d3639230-cc84-494e-9eb3-b936e9b97055 33 fields · synced May 29, 2026