| Primary Device ID | G225SS1B30 | 
| NIH Device Record Key | 6570ef87-8bd2-45d0-9506-40f7eef9f7cb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Oncore Pro | 
| Version Model Number | SS1-B3 | 
| Company DUNS | 845346506 | 
| Company Name | Pathcom Systems Corporation | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | G225SS1B30 [Primary] | 
| KPA | Slide Stainer, Automated | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-05-09 | 
| Device Publish Date | 2022-05-01 | 
| G225SS1Z0 - Nova Aura | 2024-04-16 The Nova Aura Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sectio | 
| G225SS1N0 - Histostainer AT | 2022-06-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225PATSS10 - MD Stainer | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225QHDX360 - Quantum HDx | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225QSSX370 - Quantum S2 | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225SS10 - Slide Stainer | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225SS1B30 - Oncore Pro | 2022-05-09The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories. | 
| G225SS1B30 - Oncore Pro | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| G225SS1DBS0 - High Lighter | 2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ONCORE PRO  97352331  not registered Live/Pending | Biocare Medical, LLC 2022-04-07 |