| Primary Device ID | 00380740081065 |
| NIH Device Record Key | 80939332-cd38-48b6-9242-e87a92ac2e7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCHITECT |
| Version Model Number | 7K65-32 |
| Catalog Number | 07K6532 |
| Company DUNS | 989964119 |
| Company Name | ABBOTT IRELAND |
| 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 | 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740081065 [Primary] |
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
| 00380740142759 | ARCHITECT 25-OH Vitamin D Controls |
| 00380740142742 | ARCHITECT 25-OH Vitamin D Calibrators |
| 00380740129507 | ARCHITECT Total T4 Reagent Kit (500T) |
| 00380740129491 | ARCHITECT Total T4 Reagent Kit (2000T) |
| 00380740129484 | ARCHITECT Total T4 Reagent Kit (100T) |
| 00380740129460 | ARCHITECT Total T4 Controls |
| 00380740129453 | ARCHITECT Total T4 Calibrators |
| 00380740119812 | ARCHITECT Free T4 Reagent Kit (500T) |
| 00380740119805 | ARCHITECT Free T4 Reagent Kit (2000T) |
| 00380740119799 | ARCHITECT Free T4 Reagent Kit (100T) |
| 00380740117818 | ARCHITECT 25-OH Vitamin D Reagent Kit (2000T) |
| 00380740116446 | ARCHITECT 25-OH Vitamin D Reagent Kit (500T) |
| 00380740116439 | ARCHITECT 25-OH Vitamin D Reagent Kit (100T) |
| 00380740106065 | ARCHITECT ESTRADIOL REAGENT KIT 1 x 500 |
| 00380740106058 | ARCHITECT PROGESTERONE REAGENT KIT 1 x 500 |
| 00380740105990 | ARCHITECT Prolactin Reagent Kit (500T) |
| 00380740105983 | ARCHITECT FSH Reagent Kit (500T) |
| 00380740105976 | ARCHITECT Ferritin Reagent Kit (500T) |
| 00380740105969 | ARCHITECT TSH Reagent Kit (500T) |
| 00380740105952 | ARCHITECT Total T4 Reagent Kit (500T) |
| 00380740105945 | ARCHITECT Total T3 Reagent Kit (500T) |
| 00380740105938 | ARCHITECT Free T4 Reagent Kit (500T) |
| 00380740105921 | ARCHITECT Free T3 Reagent Kit (500T) |
| 00380740081126 | ARCHITECT Free T4 Reagent Kit (100T) |
| 00380740081065 | ARCHITECT Free T4 Reagent Kit (2000T) |
| 00380740081034 | ARCHITECT Free T4 Calibrators |
| 00380740014971 | ARCHITECT Total Beta hCG Reagent Kit (2000T) |
| 00380740014964 | ARCHITECT Total Beta hCG Reagent Kit (100T) |
| 00380740014940 | ARCHITECT Total Beta hCG Controls |
| 00380740014933 | ARCHITECT Total Beta hCG Calibrators |
| 00380740014926 | ARCHITECT Progesterone Manual Diluent |
| 00380740014919 | ARCHITECT Progesterone Reagent Kit (100T) |
| 00380740014896 | ARCHITECT Progesterone Controls |
| 00380740014889 | ARCHITECT Progesterone Calibrators |
| 00380740014865 | ARCHITECT Prolactin Reagent Kit (100T) |
| 00380740014841 | ARCHITECT Prolactin Controls |
| 00380740014834 | ARCHITECT Prolactin Calibrators |
| 00380740014810 | ARCHITECT FSH Reagent Kit (100T) |
| 00380740014797 | ARCHITECT FSH Controls |
| 00380740014780 | ARCHITECT FSH Calibrators |
| 00380740014728 | ARCHITECT Estradiol Manual Diluent |
| 00380740014711 | ARCHITECT Estradiol Reagent Kit (100T) |
| 00380740014698 | ARCHITECT Estradiol Controls |
| 00380740014681 | ARCHITECT Estradiol Calibrators |
| 00380740014445 | ARCHITECT Total T4 Reagent Kit (2000T) |
| 00380740014438 | ARCHITECT Total T4 Reagent Kit (100T) |
| 00380740014414 | ARCHITECT Total T4 Controls |
| 00380740014407 | ARCHITECT Total T4 Calibrators |
| 00380740014360 | ARCHITECT Free T4 Controls |
| 00380740014346 | ARCHITECT Total T3 Manual Diluent |