HairCheck-DT (Amphetamines)

GUDID 00868586000230

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.

Quest Diagnostics

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• Primary Device ID: 00868586000230
• NIH Device Record Key: aeecb348-73f2-4265-99ce-ae07c97e0517
• Commercial Distribution Discontinuation: 2018-03-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HairCheck-DT (Amphetamines)
• Version Model Number: K051161
• Company DUNS: 189222334
• Company Name: Quest Diagnostics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• 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	00868586000230 [Primary]

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-11
• Device Publish Date: 2016-09-23

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