| Primary Device ID | EBUHKKACK21 |
| NIH Device Record Key | 8bb9dcc1-9080-40ec-adb6-60c6106fae72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE Kinetic Kit |
| Version Model Number | KK-ACK2 |
| Catalog Number | KK-ACK2 |
| Company DUNS | 481261006 |
| Company Name | Bühlmann Laboratories AG |
| 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 | 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 |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBUHKKACK21 [Primary] |
| KQN | Radioassay, Angiotensin Converting Enzyme |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| EBUHKKACKX1 | The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost |
| EBUHKKACK41 | The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost |
| EBUHKKACK21 | The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnost |