ELITechGroup
GUDID 03661540304088
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ELITECHGROUP INC.
Chloride coulometric titration analyser IVD, semi-automated| Primary Device ID | 03661540304088 |
| NIH Device Record Key | 352969af-174c-4906-b6f8-b4a4d988de45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELITechGroup |
| Version Model Number | Model 3400 |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540304088 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121823
FDA Product Code
| JFS | Coulometric, Chloride |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ELITechGroup]
| 03661540304088 | The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic de |
| 03661540303975 | The Cytopro Cytocentrifuge is an in vitro diagnostic medical device for fixing biological cell s |
| 03661540303951 | Model 7322 |
Trademark Results [ELITechGroup]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELITECHGROUP 85927180 4822550 Live/Registered |
Wescor Inc. 2013-05-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.