| Primary Device ID | 00380740151706 | 
| NIH Device Record Key | f5e098c1-0373-43fd-b29b-b4d8acd40d7b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Alinity | 
| Version Model Number | 08P361A | 
| Catalog Number | 08P361A | 
| Company DUNS | 315786293 | 
| Company Name | Abbott GmbH & Co. KG | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | |
| Phone | +1(877)422-2688 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00380740151706 [Primary] | 
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-08-30 | 
| Device Publish Date | 2018-07-30 | 
| 00380740166441 | Alinity c Lithium Assay File | 
| 00380740162832 | Alinity c Bili Total Assay File | 
| 00380740161941 | Alinity c UIBC Assay File | 
| 00380740160807 | Alinity i B_hCG Assay File | 
| 00380740160791 | Alinity c Iron Assay File | 
| 00380740158460 | Alinity ci-series Reagent Cartridge, Black (Large) | 
| 00380740158422 | Alinity c Total Bilirubin Reagent Kit 3600 Tests | 
| 00380740158415 | Alinity c Total Bilirubin Reagent Kit 2750 Tests | 
| 00380740155919 | Alinity i CA 19-9XR Reagent Kit 200 Tests | 
| 00380740155797 | Alinity i tHCY-DIL Assay File | 
| 00380740154493 | Alinity i C-Peptide Reagent Kit 200 Tests | 
| 00380740154486 | Alinity i Homocysteine Controls | 
| 00380740154479 | Alinity i Homocysteine Calibrators | 
| 00380740154462 | Alinity i C-Peptide Calibrators | 
| 00380740154325 | Alinity c Lipid Multiconstituent Calibrator Kit | 
| 00380740153526 | Alinity i C-Peptide Controls | 
| 00380740153496 | Alinity i Homocysteine Reagent Kit 200 Tests | 
| 00380740153458 | Alinity c-series Detergent B | 
| 00380740152864 | Alinity c Iron Calibrator Kit | 
| 00380740152123 | Alinity c Valproic Assay File | 
| 00380740152109 | Alinity c Tobra Assay File | 
| 00380740152093 | Alinity c Theo Assay File | 
| 00380740152062 | Alinity c Prealbumin Assay File | 
| 00380740152055 | Alinity c Phenobarb Assay File | 
| 00380740151843 | Alinity c ASO Assay File | 
| 00380740151812 | Alinity c Amikacin Assay File | 
| 00380740151799 | Alinity c a1AT Assay File | 
| 00380740151768 | Alinity c B2M Assay File | 
| 00380740151737 | Alinity i SHBG Assay File | 
| 00380740151706 | Alinity i Progest Assay File | 
| 00380740151690 | Alinity i PCT Assay File | 
| 00380740151621 | Alinity i LH Assay File | 
| 00380740151614 | Alinity i Insulin Assay File | 
| 00380740151607 | Alinity i tHCY-UNDIL Assay File | 
| 00380740151553 | Alinity i FSH Assay File | 
| 00380740151485 | Alinity i C-Peptide Assay File | 
| 00380740151447 | Alinity i VitB12 Assay File | 
| 00380740151430 | Alinity i Anti-TPO Assay File | 
| 00380740151423 | Alinity i Anti-Tg Assay File | 
| 00380740151416 | Alinity i Anti-CCP Assay File | 
| 00380740151393 | Alinity i SHBG Reagent Kit | 
| 00380740151386 | Alinity i SHBG Controls | 
| 00380740151379 | Alinity i SHBG Calibrators | 
| 00380740151362 | Alinity i Anti-CCP Reagent Kit 200 Tests | 
| 00380740151355 | Alinity i Anti-CCP Controls | 
| 00380740151348 | Alinity i Anti-CCP Calibrators | 
| 00380740151256 | Alinity c Prealbumin Calibrator Kit | 
| 00380740151089 | Alinity c Specific Proteins Multiconstituent Calibrator Kit | 
| 00380740150914 | Alinity i Testo 2G Assay File | 
| 00380740150815 | Alinity i Insulin Reagent Kit 200 Tests | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ALINITY  97548714  not registered Live/Pending | Matthew Kubicek 2022-08-15 | 
|  ALINITY  86505125  not registered Dead/Abandoned | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505124  5908335 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505123  not registered Dead/Abandoned | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505098  not registered Dead/Abandoned | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505096  5576114 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505094  5607328 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505092  5601535 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505089  5601534 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86505088  5601533 Live/Registered | Abbott Laboratories 2015-01-15 | 
|  ALINITY  86456946  not registered Dead/Abandoned | WORKFRONT, INC. 2014-11-17 | 
|  ALINITY  85043533  not registered Dead/Abandoned | JBZ&A, Inc. 2010-05-20 |