| Primary Device ID | 10888234001836 |
| NIH Device Record Key | dc19480b-ed26-49c5-862c-2a36e227312f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-K |
| Version Model Number | 0004140 |
| Catalog Number | 0004140 |
| Company DUNS | 061446282 |
| Company Name | IMMUCOR, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234001836 [Primary] |
| 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 | 2016-06-04 |
| 10888234001836 | This polyclonal reagent is used for the detection of the K antigen (of the Kell blood group syst |
| 10888234000761 | This reagent is used for the detection of the k antigen on red blood cells by tube test. This pr |