| Primary Device ID | 00708872000011 |
| NIH Device Record Key | 02b7de8e-66e6-4d50-983b-4754dc9a622f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heparin/PF4 Antibody Serum Panel |
| Version Model Number | 4036028 |
| Catalog Number | 4036028 |
| Company DUNS | 611245549 |
| Company Name | AKERS BIOSCIENCES, INC. |
| Device Count | 6 |
| 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 | 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 |
| Phone | 8568488698 |
| mrodriguez@akersbio.com | |
| Phone | 8568488698 |
| mrodriguez@akersbio.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and -70 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00708872000011 [Primary] |
| GS1 | 01708872000011 [Unit of Use] |
| GGN | Plasma, Coagulation Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-05 |
| 00708872000011 | The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a |
| 00708872000004 | The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a |