| Primary Device ID | 00613745012018 |
| NIH Device Record Key | dc5cfdb0-a693-499a-aceb-5b087a040c40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ImmunoFA Toxoplasma Slides |
| Version Model Number | 800-1201 |
| Catalog Number | 1201 |
| 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 | 00613745012018 [Primary] |
| GLZ | Antigens, If, Toxoplasma Gondii |
| 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 |
| 00613745012070 | For use with ImmunoFA Toxoplasma kits |
| 00613745012018 | Toxoplasma Slides for use with ImmunoFA Toxoplasma kits |