| Primary Device ID | 00810055813094 | 
| NIH Device Record Key | ac332e4c-f079-4b5c-88b5-79ca02adbcaa | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SoftCytogenetics | 
| Version Model Number | 4.1.17.5 | 
| Company DUNS | 131311409 | 
| Company Name | SCC SOFT COMPUTER | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| 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 | 
|---|---|
| GS1 | 00810055813094 [Primary] | 
| JQP | Calculator/Data Processing Module, For Clinical Use | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-07-09 | 
| Device Publish Date | 2021-07-01 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SOFTCYTOGENETICS  76675598  3361252 Live/Registered | Soft Computer Consultants, Inc. 2007-04-17 |