Primary Device ID | 42601861205090 |
NIH Device Record Key | 07d16d70-128f-4240-bed0-00d4f75b20dc |
Commercial Distribution Discontinuation | 2020-03-02 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | HELIOS |
Version Model Number | AUTOMATED IFA SYSTEM |
Catalog Number | IOS-1000 |
Company DUNS | 341702675 |
Company Name | Aesku.Systems GmbH & Co. KG |
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 | true |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 42601861205090 [Primary] |
DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-03-03 |
Device Publish Date | 2016-09-27 |
42601861205090 | Automated system for immunofluorescence processing with an integrated fluorescence microscope an |
04260186125096 | Automated system for immunofluorescence processing with an integral fluorescence microscope and |