Primary Device ID | B110ANK1200 |
NIH Device Record Key | 583ae03d-aeef-4ba1-bacb-7f0ce90504dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ANA (HEp-2) Test System, 120 Tests |
Version Model Number | ANK-120 |
Catalog Number | ANK-120 |
Company DUNS | 024824641 |
Company Name | Bion Enterprises, Ltd. |
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 |