Macroduct® Sweat Collection System
GUDID 03661540303388
The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.
ELITECHGROUP INC.
Sweat-induction iontophoresis system| Primary Device ID | 03661540303388 |
| NIH Device Record Key | d9daa9e4-664c-41f4-9fd3-32b341c9aecc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Macroduct® Sweat Collection System |
| Version Model Number | Model 3700 |
| 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 | 03661540303388 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K853973
FDA Product Code
| KTB | Device, Iontophoresis, Specific Uses |
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 | 2021-02-23 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by ELITECHGROUP INC.
| 03661540300035 - Microsed-System® Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300042 - Mix-Rate® X20 Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300202 - Monosed® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300219 - Monosed® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300257 - Excyte® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300264 - Excyte® ESR Vacuum Tube, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300271 - Excyte® ESR Vacuum Tube, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
Trademark Results [Macroduct]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACRODUCT 74288931 1758172 Live/Registered |
ELITECHGROUP INC. 1992-06-26 |
 MACRODUCT 73537998 1379034 Dead/Cancelled |
WESCOR, INC. 1985-05-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.