| Primary Device ID | 04061609000538 | 
| NIH Device Record Key | 0d94d653-f1d4-4406-b078-f12f67be9289 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | TIC® 20 µL Capillary Pack (Plastic) | 
| Version Model Number | TIC-CP20P | 
| Company DUNS | 327536728 | 
| Company Name | BIOANALYTIC GmbH, biomed. Analysentechnik | 
| 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 | 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 | 04061609000538 [Primary] | 
| GIO | Tube, Collection, Capillary Blood | 
| 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 |