| Primary Device ID | 05060242471162 |
| NIH Device Record Key | f84e269f-8983-4a82-9de8-79546292c5fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALBAcyte IgG Sensitized Red Blood Cells |
| Version Model Number | Z441U |
| Company DUNS | 516536641 |
| Company Name | ALBA BIOSCIENCE LIMITED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060242471162 [Primary] |
| KSF | Kit, Quality Control For Blood Banking Reagents |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2016-09-24 |
| 05060242477959 - ALBA Elution Kit | 2023-10-23 The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detectio |
| 10758750006144 - FETALSCREEN™II | 2022-03-31 FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation. |
| 10758750013005 - ORTHOTM Sera Anti-Fya | 2022-03-31 The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect |
| 10758750013012 - ORTHOTM Sera Anti-Fyb | 2022-03-31 The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect |
| 10758750013029 - ORTHOTM Sera Anti-Jka | 2022-03-31 The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct ag |
| 10758750013036 - ORTHOTM Sera Anti-Jkb | 2022-03-31 The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the direct ag |
| 10758750013043 - ORTHOTM Sera Anti-S | 2022-03-31 The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect ant |
| 10758750013050 - ORTHOTM Sera Anti-s | 2022-03-31 The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirect ant |