Identity
- Trade Name
- Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL FDA UDI
- Generic Name
- Chloride (Cl-) IVD, calibrator FDA UDI
- Device Name
- ELITechGroup's calibrator solution is for calibration of the Sweat-Chek™ Sweat Conductivity Analyzer. FDA UDI
- Model / Reference
- SS-140 FDA UDI
- Description
- ELITechGroup's calibrator solution is for calibration of the Sweat-Chek™ Sweat Conductivity Analyzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540302886 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Chloride (Cl-) IVD, calibrator 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chloride (Cl-) IVD, calibrator
Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chloride (Cl-) IVD, calibrator.
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · 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 6c86b3ce-a57a-4129-ab5a-14d67ea89c86 34 fields · synced May 31, 2026