FDA UDI
In Commercial Distribution
🇺🇸 United States
Quest Diagnostics Oral Fluid Oxycodone HEIA
DI: 00868586000292
·
Model: PVH-Exempt
·
Quest Diagnostics
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quest Diagnostics Oral Fluid Oxycodone HEIA
- Primary DI
- 00868586000292
- Version / Model
- PVH-Exempt
- Company Name
- Quest Diagnostics
- Labeler DUNS
- 189222334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 08cb9838-a006-40b8-a19e-cbd0d618eae8
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | Clinical Toxicology | 862.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55717 | Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) | 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 | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868586000292 | GS1 |