| Primary Device ID | 00850054552013 |
| NIH Device Record Key | e552ab69-d8c3-4988-89a7-235545979639 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | US Agent Collection Oral Fluid Kit |
| Version Model Number | 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 | true |
| 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 | 00850054552013 [Primary] |
| GS1 | 10850054552010 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 20850054552017 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 30850054552014 [Package] Package: [25 Units] In Commercial Distribution |
| GS1 | 40850054552011 [Package] Package: [100 Units] In Commercial Distribution |
| KDT | Container, Specimen Mailer And Storage, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-23 |
| Device Publish Date | 2024-01-15 |
| 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 | 2024-01-23US Agent Collection Oral Fluid Kit |
| 00850054552013 - US Agent Collection Oral Fluid Kit | 2024-01-23 US Agent Collection Oral Fluid Kit |
| 00869419000298 - Multi Use 9 drug (CASE) | 2024-01-01 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 |