NOVEOS 63000
GUDID 00816879022995
The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.
HYCOR BIOMEDICAL LLC
Chemiluminescent immunoassay analyser IVD, automated| Primary Device ID | 00816879022995 |
| NIH Device Record Key | 924cc5bb-e3bc-417f-8fa3-96ef2b0c556c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVEOS |
| Version Model Number | Immunoassay Analyzer |
| Catalog Number | 63000 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879022995 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182479
FDA Product Code
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-16 |
| Device Publish Date | 2021-12-08 |
Devices Manufactured by HYCOR BIOMEDICAL LLC
Trademark Results [NOVEOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVEOS 87493821 not registered Live/Pending |
Hycor Biomedical LLC 2017-06-16 |
 NOVEOS 87481048 not registered Live/Pending |
Hycor Biomedical LLC 2017-06-08 |
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