| Primary Device ID | 07290019819066 |
| NIH Device Record Key | a8b6562b-adf2-4c63-98b7-caab83ad0f6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IBDX ASR PLATE CHITOBIOSIDE |
| Version Model Number | C302100 |
| Company DUNS | 531861160 |
| Company Name | GLYCOMINDS DIAGNOSTICS (2014) 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| 07290019819066 - IBDX ASR PLATE CHITOBIOSIDE | 2023-07-24IBDX ASR PLATE CHITOBIOSIDE contains an immobilized Chitobioside glycan that can be used to detect the presence of anti-Chitobioside antibodies. Analytical and performance characteristics are not established. |
| 07290019819066 - IBDX ASR PLATE CHITOBIOSIDE | 2023-07-24 IBDX ASR PLATE CHITOBIOSIDE contains an immobilized Chitobioside glycan that can be used to detect the presence of anti-Chitobio |
| 07290019819073 - IBDX ASR PLATE LAMINARIBIOSIDE | 2023-07-24 IBDX ASR PLATE LAMINARIBIOSIDE contains an immobilized Laminaribioside glycan that can be used to detect the presence of anti-La |
| 07290019819080 - IBDX ASR PLATE MANNOBIOSIDE | 2023-07-24 IBDX ASR PLATE MANOBIOSIDE contains an immobilized Manobioside glycan that can be used to detect the presence of anti-Manobiosid |
| 07290019819097 - IBDX ASR PLATE SACCHAROMYCES | 2023-07-24 IBDX ASR PLATE SACCHAROMYCES contains an immobilized glycan purified from saccharomyces cerevisiae that can be used to detect th |