| Primary Device ID | 04061609000088 |
| NIH Device Record Key | 430bca01-c037-4507-bb06-f9b6fdc3af55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leuko-TIC SF 1:100 plus |
| Version Model Number | 004008-6100 |
| Company DUNS | 327536728 |
| Company Name | BIOANALYTIC GmbH, biomed. Analysentechnik |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| 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 | 04061609000088 [Primary] |
| GS1 | 04061609000576 [Unit of Use] |
| JCG | Fluid, Diluting, Manual Cell |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-06 |
| 04061609000699 - Thrombo-TIC 1:100 pur | 2019-03-04 |
| 04061609000712 - Thrombo-TIC 1:25 pur | 2019-03-04 |
| 04061609000736 - Thrombo-TIC 1:25 pur | 2019-03-04 |
| 04061609000019 - Sperm-TIC 1:20 | 2018-03-29 For microscopic counting of Sperms. (5 Tests) |
| 04061609000026 - Sperm-TIC 1:20 plus | 2018-03-29 For microscopic counting of Sperms. (100 Tests) |
| 04061609000033 - Ejaculate-TIC 1:20 | 2018-03-29 |
| 04061609000040 - Ejaculate-TIC 1:20 plus | 2018-03-29 |
| 04061609000057 - Leuko-TIC VT | 2018-03-29 |