| Primary Device ID | 00380740175146 |
| NIH Device Record Key | fd0d802f-3357-417d-9699-8cda8a6a042a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCHITECT |
| Version Model Number | 9D93-22 |
| Catalog Number | 09D9322 |
| Company DUNS | 315786293 |
| Company Name | Abbott GmbH |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740175146 [Primary] |
| DFC | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2020-12-15 |
| 00380740175429 | Prealbumin Calibrator |
| 00380740175122 | Specific Proteins Multiconstituent |
| 00380740161361 | Multiconstituent Calibrator |
| 00380740161385 | Bilirubin Calibrator |
| 00380740175146 | Apolipoprotein B |
| 00380740175139 | Apolipoprotein A1 |
| 00380740175153 | Complement C3 |
| 00380740175160 | Complement C4 |
| 00380740161446 | Transferrin |
| 00380740161439 | Transferrin |
| 00380740175184 | Immunoglobulin G |
| 00380740175177 | Immunoglobulin A |
| 00380740175115 | Immunoglobulin M |