| Primary Device ID | B24235B2SHUE010 |
| NIH Device Record Key | 2a35efec-4f83-490a-9851-873767e7d1d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-Beta 2 Glycoprotein Screen ELISA |
| Version Model Number | 35-B2SHU-E01 |
| Catalog Number | 35-B2SHU-E01 |
| Company DUNS | 784143778 |
| Company Name | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 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 | 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 | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B24235B2SHUE010 [Primary] |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
| 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 | 2017-08-28 |
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