| Primary Device ID | 00089686302042 |
| NIH Device Record Key | 2f601081-1643-4b74-9bd4-7ecd90bd5b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chromascopics Control Level 1&2 Set 4x120mL (Domes |
| Version Model Number | 1540-02 |
| Catalog Number | 1540-02 |
| Company DUNS | 010717890 |
| Company Name | QUANTIMETRIX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does n |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (310) 536-0006 |
| sales@quantimetrix.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00089686302042 [Primary] |
| HIBCC | M0511540021 [Secondary] |
| JJW | Urinalysis Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2018-09-26 |
| 00896863002424 - Chromascopics Control Level 1&2 Set 2x25mL (International) | 2023-05-12 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus |
| 00896863002356 - QuanTtest Human Protein Standards Set | 2021-09-20 QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay Sys |
| 00896863002004 - Dropper Spinal Fluid Control Level 1 Set 3x3mL | 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p |
| 00896863002011 - Dropper Spinal Fluid Control Level 2 Set 3x3mL | 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p |
| 00896863002073 - Dropper Spinal Fluid Control Level 1&2 Set 2x3mL | 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p |
| 00896863002042 - Chromascopics Control Level 1&2 Set 4x120mL (Domestic) | 2020-01-10 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus |
| M0515210120 - QuanTtest Red Pyrogallol Red Reagent | 2019-10-07 QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in a |
| 00089686302042 - Chromascopics Control Level 1&2 Set 4x120mL (Domes | 2018-10-29The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemis |
| 00089686302042 - Chromascopics Control Level 1&2 Set 4x120mL (Domes | 2018-10-29 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus |