| Primary Device ID | 15099590540807 |
| NIH Device Record Key | 1c59f5d7-dd33-4808-a1c3-04ca42a566d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Manual CD4 Count Kit |
| Version Model Number | 6603876 |
| Catalog Number | 6603876 |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, 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 | 15099590540807 [Primary] |
| GKZ | Counter, Differential Cell |
| 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 |
| 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 |
| 15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay 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 |
| 15099590209636 - DxH | 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and |