| Primary Device ID | 00613745039183 |
| NIH Device Record Key | 0df9c1e6-e513-4d26-acb1-61b019230b6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ImmunoDOT Serum Control D |
| Version Model Number | 800-3918 |
| Catalog Number | 3918 |
| Company DUNS | 940425333 |
| Company Name | Genbio |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 | 00613745039183 [Primary] |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
| 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 | 2016-09-24 |
| 00613745000046 - ImmunoDOT Leptospira IgM | 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp |
| 00613745000152 - ImmunoDOT Leptospira IgM | 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp |
| 00613745000169 - ImmunoDOT Leptospira IgM | 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp |
| 00613745010052 - ImmunoFA 10x PBS | 2018-07-06 10-fold concentrate of 0.01M PBS |
| 00613745010069 - ImmunoFA 10x PBS | 2018-07-06 10-fold concentrate of 0.01M PBS |
| 00613745010250 - ImmunoFA Mounting Fluid | 2018-07-06 Mounting fluid for use with ImmunoFA kits. |
| 00613745012001 - ImmunoFA Toxoplasma IgG | 2018-07-06 The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii |
| 00613745012018 - ImmunoFA Toxoplasma Slides | 2018-07-06 Toxoplasma Slides for use with ImmunoFA Toxoplasma kits |