Primary Device ID | M5255526970 |
NIH Device Record Key | 4dfcaf7f-0e9a-4980-b658-1302714f26c9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPIFE Nexus Antisera 9/15 Kit |
Version Model Number | 552697 |
Company DUNS | 079396131 |
Company Name | HELENA LABORATORIES CORPORATION |
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 | false |
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 | true |
OTC Over-The-Counter | false |