Primary Device ID | 00869419000298 |
NIH Device Record Key | 7b29947b-45b2-43ce-9c33-20fae6e2d320 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Multi Use 9 drug (CASE) |
Version Model Number | DUE-197-232 (FUO) |
Company DUNS | 189222334 |
Company Name | Quest Diagnostics |
Device Count | 25 |
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 | false |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00869419000298 [Unit of Use] |
GS1 | 10869419000264 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-01 |
Device Publish Date | 2023-12-22 |
10850054552034 - US Blood And Urine Kit | 2024-05-09 US Blood And Urine Kit |
10850054552041 - US Paramed Collection Oral Fluid Kit | 2024-05-09 US Paramed Collection Oral Fluid Kit |
10850054552058 - US Urine Examiner Kit | 2024-05-09 US Urine Examiner Kit |
00850054552013 - US Agent Collection Oral Fluid Kit | 2024-01-23 US Agent Collection Oral Fluid Kit |
00869419000298 - Multi Use 9 drug (CASE) | 2024-01-01Multi Use 9 drug (CASE) |
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 |