HairCheck-DT (THC) Exempt

GUDID 00868586000261

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.

Quest Diagnostics

Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00868586000261
• NIH Device Record Key: d3639230-cc84-494e-9eb3-b936e9b97055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HairCheck-DT (THC) Exempt
• Version Model Number: PVJ-Exempt
• Company DUNS: 189222334
• Company Name: Quest Diagnostics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868586000261 [Primary]

FDA Product Code

• PVJ: Test, Cannabinoid, Employment And Insurance Testing, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-19
• Device Publish Date: 2023-07-11

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