| Primary Device ID | 10873037000070 |
| NIH Device Record Key | 7ec9f7df-8829-4bf8-b988-25b276f2f360 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cytofuge |
| Version Model Number | X00-003066-001 |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 10873037000070 [Primary] |
| IFB | Cytocentrifuge |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-01 |
| Device Publish Date | 2020-08-24 |
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| 15099590806415 - ACCESS anti-HAV | 2026-01-26 The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of tot |
| 15099590806422 - ACCESS anti-HAV CALIBRATOR | 2026-01-26 The Access anti-HAV Calibrator is intended to calibrate the Access anti-HAV assay for the in vitro qualitative detection of anti |
| 15099590806439 - ACCESS anti-HAV QC | 2026-01-26 The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for |
| 15099590799717 - MicroScan | 2025-12-25 MicroScan LabPro V5.03 System (US), Electronic |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CYTOFUGE 74535105 1948107 Live/Registered |
BECKMAN COULTER, INC. 1994-06-08 |