FDA UDI
In Commercial Distribution
🇺🇸 United States
ChloroChek® Chloridometer® Sweat Chloride Analyzer
DI: 03661540304088
·
Model: Model 3400
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ChloroChek® Chloridometer® Sweat Chloride Analyzer
- Primary DI
- 03661540304088
- Version / Model
- Model 3400
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-02-23
- Public Version Status
- Update
- Public Device Record Key
- 352969af-174c-4906-b6f8-b4a4d988de45
Device Description
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JFS | Coulometric, Chloride | Clinical Chemistry | 862.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60045 | Chloride coulometric titration analyser IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of chloride in a clinical specimen (e.g., sweat, urine, serum or other body fluids) using a coulometric titration. Typically, a constant current is applied to the introduced sample to reduce chloride ions that are present in the solution and the magnitude and duration of the current prior to reaching the endpoint is used to determine the chloride concentration in relation to a reference solution. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540304088 | GS1 |
Customer Contacts
- Phone
- 1-800-453-2725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121823 | 000 |