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.

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 Oral Fluid Oxycodone HEIA - PVH-Exempt

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PVH

Device Name: Test, Opiates, Employment And Insurance Testing, Exempt

Device Class: 2

Physical State: In vitro diagnostic device

Definition: The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.

Submission Type ID: 4

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Immunoassay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro specimen

Regulation Number: 862.3650

Third Party Flag: N

Medical Specialty: TX

Device Id: 00868586000292

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A