Identity
- Trade Name
- Nanoduct® Calibration Standard Plate FDA UDI
- Generic Name
- Sweat-induction iontophoresis device/conductivity analyser FDA UDI
- Device Name
- For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic Fibrosis. FDA UDI
- Model / Reference
- AC-081 FDA UDI
- Description
- For use with Nanoduct Neonatal Sweat Analysis System to calibrate the conductivity measurement of sweat for diagnosis of Cystic Fibrosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540301124 FDA UDI
- 510(k) Number
- K010031 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Sweat-induction iontophoresis device/conductivity analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sweat-induction iontophoresis device/conductivity analyser
Nanoduct® Calibration Standard Plate by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sweat-induction iontophoresis device/conductivity analyser.
- Nanoduct® Pos (+) Red Holder, Qty 1 — ELITECHGROUP INC. · Class II
- Nanoduct® Attachment Strap Retainer Post, Qty 1 — ELITECHGROUP INC. · Class II
- Nanoduct® Electrode Strap, Large, Qty 1 — ELITECHGROUP INC. · Class II
- Nanoduct® Conductivity Sensor Cell, Qty 1 — ELITECHGROUP INC. · Class II
- Nanoduct Neonatal Sweat Analysis System — ELITECHGROUP INC. · Class II
- Nanoduct® Electrode Strap, Small, Qty 1 — ELITECHGROUP INC. · Class II
- Nanoduct® Electrode Cable Set Assembly — ELITECHGROUP INC. · Class II
- Nanoduct® Electrode Strap, Medium, Qty 1 — ELITECHGROUP INC. · Class II
Cleared under the same submission
K010031 also covers:
- Nanoduct Neonatal Sweat Analysis System — ELITECHGROUP INC.
- Nanoduct® Attachment Strap Retainer Post, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Conductivity Sensor Cell, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Electrode Cable Set Assembly — ELITECHGROUP INC.
- Nanoduct® Electrode Strap, Large, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Electrode Strap, Medium, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Electrode Strap, Small, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Neg (-) Black Holder, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Pos (+) Red Holder, Qty 1 — ELITECHGROUP INC.
- Nanoduct® Supply Kit, Qty 6 — ELITECHGROUP INC.
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 63f64175-8aed-4948-94f5-ba81fd87d5a5 35 fields · synced May 29, 2026