| Primary Device ID | 15099590669263 |
| NIH Device Record Key | 0fe7738b-ebe4-4776-beb9-342567602a5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Access AMH |
| Version Model Number | B13127 |
| Catalog Number | B13127 |
| 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 | 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 | 15099590669263 [Primary] |
| PQO | Anti-Müllerian Hormone Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-16 |
| Device Publish Date | 2018-03-16 |
| 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 |
| 15099590762889 - Stem-Kit Reagents | 2024-11-04 Stem-Kit Reagents |
| 15099590762896 - StemTrol Control Cells | 2024-11-04 StemTrol Control Cells |
| 15099590732103 - DxI 9000 Access Immunoassay Analyzer | 2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali |
| 15099590575243 - Access hLH | 2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing |
| 15099590760823 - Access NT-proBNP | 2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term |
| 15099590760830 - ACCESS NT-proBNP CALIBRATORS | 2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te |
| 15099590772840 - Access Ferritin | 2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti |