| Primary Device ID | 10627944000094 |
| NIH Device Record Key | cf39613f-32fc-49ba-87be-a9fde53015f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuikCoag Calcium Chloride 0.02M |
| Version Model Number | 4 mL |
| Company DUNS | 200152713 |
| Company Name | Biomedica Diagnostics Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627944000097 [Primary] |
| GS1 | 10627944000094 [Package] Contains: 00627944000097 Package: Box [10 Units] In Commercial Distribution |
| GFO | Activated Partial Thromboplastin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-09-22 |
| 00627944000011 - QuikCoag PT-HS | 2020-02-24 |
| 00627944000028 - QuikCoag PT-HS | 2020-02-24 |
| 10627944000032 - QuikCoag PT-HS | 2020-02-24 |
| 00627944000042 - QuikCoag APTT-EA | 2020-02-24 |
| 00627944000059 - QuikCoag APTT-EA | 2020-02-24 |
| 10627944000063 - QuikCoag Control Level 1 Normal | 2020-02-24 |
| 10627944000070 - QuikCoag Control Level 2 Low Abnormal | 2020-02-24 |
| 10627944000087 - QuikCoag Control Level 3 High Abnormal | 2020-02-24 |