| Primary Device ID | 15099590659561 |
| NIH Device Record Key | 14a1eb3d-dd49-42f9-82e2-fcdac768e8bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MicroScan PROMPT |
| Version Model Number | B1026-10D |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, Inc. |
| Device Count | 60 |
| 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 | false |
| 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 | 05099590659564 [Unit of Use] |
| GS1 | 15099590659561 [Primary] |
| LIE | Reagent/Device, Inoculum Calibration |
| 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 |
| 15099590701673 - Access Hybritech PSA | 2025-06-09 The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of to |
| 15099590701680 - Access Hybritech free PSA | 2025-06-09 The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination |
| 15099590763626 - Access Syphilis Reagent | 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo |
| 15099590763633 - Access Syphilis Calibrators | 2025-05-15 The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. B |
| 15099590763640 - Access Syphilis QC | 2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for |
| 05099590798218 - DxH | 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid |
| 14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module | 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si |
| 14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module | 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si |