Primary Device ID | 07290019819080 |
NIH Device Record Key | 73087596-518b-4cac-aa74-2f71d88f2295 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IBDX ASR PLATE MANNOBIOSIDE |
Version Model Number | M304100 |
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 | 2023-07-24 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 | 2023-07-24IBDX ASR PLATE MANOBIOSIDE contains an immobilized Manobioside glycan that can be used to detect the presence of anti-Manobioside antibodies. Analytical and performance characteristics are not established. |
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 |