| Primary Device ID | 00810121520000 |
| NIH Device Record Key | ede165ee-34c1-4212-8c0d-bba5ead7077d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blood Specimen Collection Kit (EPH) |
| 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 | true |
| 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 | 00810121520000 [Primary] |
| KST | System, Blood Collection, Vacuum-Assisted, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-31 |
| Device Publish Date | 2023-08-23 |
| 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) | 2024-01-01 Multi Use 9 drug (CASE) |
| 00810121520000 - Blood Specimen Collection Kit (EPH) | 2023-08-31The Tasso+ Kit is a kit that includes the Tasso+ device and all supplies necessary to collect a blood sample. The Tasso+ device is a sterile, disposable blood lancing device. When collecting a sample, the device is held onto the skin by a mild adhesive. A sterile lancet punctures the skin with a press of the button, simultaneously this creates a slight vacuum that helps capillary blood flow under gravity into a compatible tube. After a predefined time period, or when the tube is full, the device is peeled off the skin. The tube is removed and capped for transport. The lancet is single use and automatically retracts into the device in a safe position after use. |
| 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 |