| Primary Device ID | 23661562105438 |
| NIH Device Record Key | b7aee317-a3fe-4317-b1b2-dd8357b7225d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neg Control |
| Version Model Number | 210543 |
| Catalog Number | 210543 |
| Company DUNS | 381527001 |
| Company Name | DIAGAST |
| Device Count | 5 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com | |
| Phone | (800) 452-6877 |
| service.americas@grifols.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 13661562105431 [Unit of Use] |
| GS1 | 23661562105438 [Primary] |
| KSF | Kit, Quality Control For Blood Banking Reagents |
| 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 | 2018-05-01 |
| 23661562495584 - Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) | 2020-10-28 Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems |
| 23661562105261 - Anti-D (RH1) IgM+IgG | 2020-03-11 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to |
| 23661562105445 - LISS | 2018-09-12 Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohemato |
| 23661562105438 - Neg Control | 2018-07-06Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique |
| 23661562105438 - Neg Control | 2018-07-06 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique |
| 23661562173178 - Beckman Coulter® PK® Systems Control | 2018-07-06 Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System |
| 23661562173307 - Beckman Coulter® PK® Systems Bromelin | 2018-07-06 Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System |
| 23661562105209 - Anti-A (AB01) | 2018-06-01 Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system |
| 23661562105216 - Anti-B (AB02) | 2018-06-01 Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system b |