| Primary Device ID | 00856626006106 |
| NIH Device Record Key | 32321d3e-8593-40e3-ba02-7e8cee2d8ff1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autokit Micro Albumin Calibrator Set |
| Version Model Number | 995-06101 |
| Catalog Number | 995-06101 |
| Company DUNS | 078629716 |
| Company Name | WAKO LIFE SCIENCES, INC. |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com | |
| Phone | 877-714-1924 |
| diagnostics@wakousa.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856626006106 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-07 |
| 00856626006168 - uTASWako AFP-L3 Calibrator Set | 2020-05-19 In-Vitro Diagnostic Use |
| 00856626006106 - Autokit Micro Albumin Calibrator Set | 2018-07-06In-Vitro Diagnostic Use |
| 00856626006106 - Autokit Micro Albumin Calibrator Set | 2018-07-06 In-Vitro Diagnostic Use |
| 00856626006113 - Autokit CH50 | 2018-07-06 In-Vitro Diagnostic Use |
| 00856626006120 - uTASWako DCP | 2018-07-06 In-Vitro Diagnostic Use |
| 00856626006151 - CH50 Calibrator | 2018-07-06 In-Vitro Diagnostic Use |
| 00856626006205 - uTASWako AFP-L3 | 2018-07-06 In-Vitro Diagnostic Use |
| 00856626006212 - μTASWako DCP Calibrator Set | 2018-07-06 In-Vitro Diagnostic Use |
| 00085662006168 - μTASWako AFP-L3 Calibrator Set | 2018-07-06 In-Vitro Diagnostic Use |