Identity
- Trade Name
- ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS FDA UDI
- Generic Name
- Chloride coulometric titration analyser IVD, semi-automated FDA UDI
- Device Name
- The ChloroChek Chloridometer Reagent Set is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration when used with the ChlorChek Chloridometer. FDA UDI
- Model / Reference
- SS-248 FDA UDI
- Description
- The ChloroChek Chloridometer Reagent Set is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration when used with the ChlorChek Chloridometer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540304095 FDA UDI
- 510(k) Number
- K121823 FDA UDI
- FDA Product Code
- JFS FDA UDI
- GMDN Term
- Chloride coulometric titration analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Chloride coulometric titration analyser IVD, semi-automated
ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 90d8859e-6c9e-4441-847f-56f5780a0423 36 fields · synced May 30, 2026