| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00858400005114 | 510265 | Red Cell Storage Solution is intended for use in the dilution and/or preservatio Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purposes of in vitro immunohematology testing. | GIF | Diluent, Blood Cell | 1 | Red Cell Storage Solution | |
| 2 | 00858400005091 | 510400/510402 | IgG-coated red blood cells used to confirm negative results in direct antiglobul IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT). | KSF | Kit, Quality Control For Blood Banking Reagents | Control Cells | ||
| 3 | 00858400005107 | 510179 | PEG is an additive solution intended for use as a potentiator in antibody detect PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution. | KSG | Media, Potentiating For In Vitro Diagnostic Use | 2 | PEG | |
| 4 | 00858400005022 | 510204 | Blood Grouping Reagent | Anti-Kpa | ||||
| 5 | 00858400005039 | 510205 | Blood Grouping Reagent | Anti-Kpb | ||||
| 6 | 00858400005008 | 510200 | Blood Grouping Reagent | Anti-K | ||||
| 7 | 00858400005121 | 510177 | LISS is an additive solution intended for use as a potentiator in antibody detec LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from glycine and albumin. | KSG | Media, Potentiating For In Vitro Diagnostic Use | 2 | LISS | |
| 8 | 00858400005084 | 510395 | Blood Bank kit used to perform quality control testing of reverse grouping and s Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells. | KSF | Kit, Quality Control For Blood Banking Reagents | 2 | DailyChek QC Kit | |
| 9 | 00858400005060 | 510224 | Blood Grouping Reagent | Anti-s | ||||
| 10 | 00858400005046 | 510206 | Blood Grouping Reagent | Anti-M | ||||
| 11 | 00858400005015 | 510202 | Blood Grouping Reagent | Anti-k | ||||
| 12 | 00858400005053 | 510222 | Blood Grouping Reagent | Anti-S |