| Primary Device ID | 00380740129927 |
| NIH Device Record Key | 82765779-a69f-4103-a0a9-530779f5ec05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alinity |
| Version Model Number | 07P5030 |
| Catalog Number | 07P5030 |
| Company DUNS | 989964119 |
| Company Name | ABBOTT IRELAND |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 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 | |
| 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 | |
| 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 |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740129927 [Primary] |
| CHP | RADIOIMMUNOASSAY, ESTRADIOL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-04 |
| Device Publish Date | 2018-12-04 |
| 00380740160616 | Alinity i Total B-hCG Reagent Kit |
| 00380740146221 | Alinity i 25-OH Vitamin D Controls |
| 00380740136710 | Alinity i Progesterone Manual Diluent |
| 00380740136703 | Alinity i B12 Reagent Kit 1200 Tests |
| 00380740136697 | Alinity i B12 Reagent Kit 200 Tests |
| 00380740136680 | Alinity i B12 Controls |
| 00380740136673 | Alinity i B12 Calibrators |
| 00380740136550 | Alinity i Folate Reagent Kit 200 Tests |
| 00380740136543 | Alinity i Folate Controls |
| 00380740136536 | Alinity i Folate Calibrators |
| 00380740131647 | Alinity i FSH Reagent Kit 1200 Tests |
| 00380740131630 | Alinity i FSH Reagent Kit 200 Tests |
| 00380740131623 | Alinity i FSH Controls |
| 00380740131616 | Alinity i FSH Calibrators |
| 00380740131524 | Alinity i Total T4 Reagent Kit 1200 Tests |
| 00380740131517 | Alinity i Total T4 Reagent Kit 200 Tests |
| 00380740131500 | Alinity i Total T4 Controls |
| 00380740131494 | Alinity i Total T4 Calibrators |
| 00380740131487 | Alinity i Ferritin Reagent Kit 1200 Tests |
| 00380740131470 | Alinity i Ferritin Reagent Kit 200 Tests |
| 00380740131463 | Alinity i Ferritin Controls |
| 00380740131456 | Alinity i Ferritin Calibrators |
| 00380740131159 | Alinity i TSH Reagent Kit 1200 Tests |
| 00380740131142 | Alinity i TSH Reagent Kit 200 Tests |
| 00380740131135 | Alinity i TSH Controls |
| 00380740131128 | Alinity i TSH Calibrators |
| 00380740130923 | Alinity i Folate Manual Diluent 1 Tests |
| 00380740129934 | Alinity i Estradiol Manual Diluent Kit 1 Tests |
| 00380740129927 | Alinity i Estradiol Reagent Kit 1000 Tests |
| 00380740129910 | Alinity i Estradiol Reagent Kit 200 Tests |
| 00380740129903 | Alinity i Estradiol Controls |
| 00380740129897 | Alinity i Estradiol Calibrators |
| 00380740121952 | Alinity i 25-OH Vitamin D Reagent Kit 1000 Tests |
| 00380740121938 | Alinity i 25-OH Vitamin D Reagent Kit 200 Tests |
| 00380740121907 | Alinity i 25-OH Vitamin D Calibrators |
| 00380740121884 | Alinity i Progesterone Reagent Kit 1000 Tests |
| 00380740121877 | Alinity i Progesterone Reagent Kit 200 Tests |
| 00380740121860 | Alinity i Progesterone Controls |
| 00380740121853 | Alinity i Progesterone Calibrators |
| 00380740121822 | Alinity i Free T4 Reagent Kit 1200 Tests |
| 00380740121815 | Alinity i Free T4 Reagent Kit 200 Tests |
| 00380740121808 | Alinity i Free T4 Controls |
| 00380740121792 | Alinity i Free T4 Calibrators |
| 00380740121587 | Alinity i Prolactin Reagent Kit 1200 Tests |
| 00380740121570 | Alinity i Prolactin Reagent Kit 200 Tests |
| 00380740121563 | Alinity i Prolactin Controls |
| 00380740121556 | Alinity i Prolactin Calibrators |
| 00380740121549 | Alinity i LH Reagent Kit 1200 Tests |
| 00380740121532 | Alinity i LH Reagent Kit 200 Tests |
| 00380740121525 | Alinity i LH Calibrators |
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 |