| Primary Device ID | 05700572001416 |
| NIH Device Record Key | 92bf4953-0e09-4422-bfb8-2ff447e61871 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Poly Rb A-Hu IgM |
| Version Model Number | A0426 |
| Company DUNS | 305047466 |
| Company Name | Dako Denmark ApS |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com | |
| Phone | +4544859500 |
| dako.dkregulatory@agilent.com |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| 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 | 05700572001416 [Primary] |
| DAO | IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2016-09-16 |
| 05700572001416 | Polyclonal Rabbit Anti-Human IgM |
| 05700572001409 | Polyclonal Rabbit Anti-Human IgM |