| Primary Device ID | B176103411 |
| NIH Device Record Key | 7d3e3570-6842-4e31-af23-a4099a88305f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IgM RID plate package |
| Version Model Number | 1 |
| Catalog Number | 103411 |
| Company DUNS | 093642254 |
| Company Name | KENT LABORATORIES INC |
| 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 | 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 | 3603988641 |
| donald@kentlabs.com | |
| Phone | 3603988641 |
| donald@kentlabs.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B176103411 [Primary] |
| CGM | Method, Immunodiffusion, Immunoglobulins (G, A, M) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| B1761080 - Antiserum to Human Properdin | 2018-09-12 Goat antiserum to human Properdin |
| B1761082 - Anti Human Properdin FITC | 2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human Complement Properdin |
| B1761210 - Antiserum to Human C-3b Inactivator (factor I) | 2018-09-12 Goat antiserum to Human C-3b Inactivator (factor I) |
| B1761212 - Anti Human C3b Inactivator FITC | 2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human C3b Inactivator |
| B1761230 - Antiserum to Human Alpha 1 Acid Glycoprotein | 2018-07-06 Goat antiserum to Human Alpha 1 Acid Glycoprotein |
| B176131 - Antiserum to Human Myoglobin | 2018-07-06 |
| B1761500 - Antiserum to Apolipoprotein A-1 | 2018-07-06 |
| B1761520 - Antiserum to Apolipprotein B | 2018-07-06 |