HairCheck-DT (Opiates)

GUDID 00868586000223

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.

Quest Diagnostics

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00868586000223
• NIH Device Record Key: 7cfe9435-b253-419d-ba3b-ddb9c2fd81e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HairCheck-DT (Opiates)
• Version Model Number: K042725
• 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	00868586000223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042725

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2018-07-06
• Device Publish Date: 2016-09-23

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