Quest Diagnostics Oral Fluid Oxycodone HEIA

GUDID 00868586000292

The Quest Diagnostics Oral Fluid Oxycodone HEIA is a Homogeneous Enzyme Immunoassay (HEIA) for the qualitative detection of Oxycodone in human oral fluid collected with the Oral‐Eze® Oral Fluid Collection System. It is a screening test with a cut off of 30 ng of oxycodone per mL (30 ng/mL) in neat oral fluid. This is an in‐vitro diagnostic device intended for laboratory use only.

Quest Diagnostics

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

• Primary Device ID: 00868586000292
• NIH Device Record Key: 08cb9838-a006-40b8-a19e-cbd0d618eae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quest Diagnostics Oral Fluid Oxycodone HEIA
• Version Model Number: PVH-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	00868586000292 [Primary]

FDA Product Code

• PVH: Test, Opiates, Employment And Insurance Testing, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-02

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