Primary Device ID | B766U310750 |
NIH Device Record Key | f539533a-4cef-4749-a20f-c5f52dd88abc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anti CD45 Antibody |
Version Model Number | U31075 |
Catalog Number | U31075 |
Company DUNS | 833074623 |
Company Name | INCELLDX, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Total Volume | 75 Microliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B766U310750 [Primary] |
MVU | Reagents, Specific, Analyte |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-13 |
Device Publish Date | 2020-02-05 |
B766C313150 - HPV E6, E7 mRNA Probe, Ready to Use | 2023-03-08 HPV E6, E7 mRNA Probe, Ready to Use is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcr |
B766C310500 - Anti PD-L1 Antibody | 2020-02-13 Anti PD-L1 Antibody is a rabbit monoclonal antibody to PD-L1 [28-8] conjugated with Alexa Fluor 647. |
B766U310750 - Anti CD45 Antibody | 2020-02-13Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoerythrin-Cyanine 7 |
B766U310750 - Anti CD45 Antibody | 2020-02-13 Anti CD45 Antibody is a mouse monoclonal antibody to CD45 [J33] conjugated with Phycoerythrin-Cyanine 7 |
B766U311000 - Anti Pan Cytokeratin Antibody | 2020-02-13 Anti Pan Cytokeratin Antibody is a mouse monoclonal antibody to cytokeratin epitopes [C-11] conjugated with Phycoerythrin (PE). |
B766C311000 - HPV E6, E7 mRNA Probe | 2019-11-21 HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a sing |