| Primary Device ID | 15099590225704 |
| NIH Device Record Key | 9aba8798-db11-4e22-9513-033ada130fad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AQUIOS Tetra-1 Panel |
| Version Model Number | B23533 |
| Catalog Number | B23533 |
| Company DUNS | 985071975 |
| Company Name | BECKMAN COULTER IRELAND INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 15099590225704 [Primary] |
| OYE | Flow Cytometric Reagents And Accessories. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 10837461002031 - iQ®200 | 2023-10-13 iQ Precision Kit |
| 10837461002147 - iQ®200 | 2023-10-13 iQ® Calibrator Pack |
| 10837461002178 - iQ®200 | 2023-10-13 iQ® Control/Focus Set (NA/INTL) |
| 10837461002239 - Iris® | 2023-10-13 Iris® Diluent Pack (NA) |
| 10837461002260 - Iris® | 2023-10-13 Iris® System Cleanser Pack (NA/INTL) |
| 10837461002307 - iQ®200 | 2023-10-13 iQ® Body Fluids Lysing Reagent (NA/INTL) |
| 10837461002345 - iQ®200 | 2023-10-13 iQ® Body Fluids Controls-Level I and Level II (NA/INTL) |
| 10837461002376 - iQ®200 | 2023-10-13 iQ® Lamina™ Case of 2 x 7 L |