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 Issuing Agency | Device ID |
---|---|
GS1 | 00868586000292 [Primary] |
PVH | Test, Opiates, Employment And Insurance Testing, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-10-02 |
00850054552013 - US Agent Collection Oral Fluid Kit | 2024-01-23 US Agent Collection Oral Fluid Kit |
00869419000298 - Multi Use 9 drug (CASE) | 2024-01-01 Multi Use 9 drug (CASE) |
00810121520000 - Blood Specimen Collection Kit (EPH) | 2023-08-31 The Tasso+ Kit is a kit that includes the Tasso+ device and all supplies necessary to collect a blood sample. The Tasso+ device |
00868586000261 - HairCheck-DT (THC) Exempt | 2023-07-19 HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of ha |
00868586000285 - General Purpose Reagent Delayed Semen Analysis Media | 2023-07-19 DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analys |
00869419000205 - Express ResultsTM | 2022-04-05 DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202) |
00869419000212 - Express ResultsTM | 2022-04-05 DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+ 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN |
00869419000243 - Express ResultsTM | 2022-04-05 DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240) |