Primary Device ID | 03661540201509 |
NIH Device Record Key | b1167080-b246-49e6-ae95-c12eb0c42e66 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENVOY 500 SERUM CALIBRATOR KIT |
Version Model Number | 55111 |
Company DUNS | 267732378 |
Company Name | ELITECH CLINICAL SYSTEMS SAS |
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 | false |
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 | true |
OTC Over-The-Counter | false |