| Primary Device ID | B24280INSHUE010 |
| NIH Device Record Key | 71d38df0-83e3-41ff-b51a-99b189fe8e93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPCO Insulin ELISA |
| Version Model Number | 80-INSHU-E01.1 |
| Catalog Number | 80-INSHU-E01.1 |
| Company DUNS | 784143778 |
| Company Name | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 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 | true |
| 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 | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com | |
| Phone | 800.592.5726 |
| cs@alpco.com |
| 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 |
|---|---|
| HIBCC | B24280INSHUE010 [Primary] |
| CFP | Radioimmunoassay, Immunoreactive Insulin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-05 |
| Device Publish Date | 2020-09-25 |
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