| Primary Device ID | 15099590671501 |
| NIH Device Record Key | 9b852b00-cdc0-4b2d-bbc3-5479ec80eb4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Access TSH (3rd IS) Calibrators |
| Version Model Number | B63285 |
| Catalog Number | B63285 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 15099590671501 [Primary] |
| JIS | Calibrator, Primary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-04-09 |
| Device Publish Date | 2016-09-28 |
| 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 |
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| 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 |