Identity
- Trade Name
- Macroduct® Sweat Collection System FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Model 3700 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- Model 3700-SYS FDA UDI
- Primary DI / UDI-DI
- 03661540303388 FDA UDI
- 510(k) Number
- K853973 FDA UDI
- FDA Product Code
- KTB FDA UDI
- GMDN Term
- Sweat-induction iontophoresis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sweat-induction iontophoresis system
Macroduct® Sweat Collection System by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sweat-induction iontophoresis system.
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- Macroduct® Collection Strap, Small, Qty 1 — ELITECHGROUP INC. · Class II
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- Macroduct® Pilogel Discs — ELITECHGROUP INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Elitechgroup Inc.
Sources (1)
- FDA UDI d9daa9e4-664c-41f4-9fd3-32b341c9aecc 36 fields · synced May 30, 2026