Identity
- Trade Name
- CLC1600 Chemistry Analyzer with ISE Module FDA UDI
- Generic Name
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- CLC1600 Clinical Chemistry Anallyzer with ISE FDA UDI
- Model / Reference
- CLC1600 FDA UDI
- Description
- CLC1600 Clinical Chemistry Anallyzer with ISE FDA UDI
Identifiers
- Catalog Number
- CLC1600i FDA UDI
- Primary DI / UDI-DI
- 00817302023114 FDA UDI
- FDA Product Code
- CGZ FDA UDICEM FDA UDIJGS FDA UDI
- GMDN Term
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 FDA UDI862.1600 FDA UDI862.1665 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Depth — 35 Inch FDA UDIHeight — 44 Inch FDA UDIWidth — 50 Inch FDA UDI
Category: Multiple electrolyte IVD, kit, ion-selective electrode (ISE)Multi-modality clinical specimen analysis system IVD
CLC1600 Chemistry Analyzer with ISE Module by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Carolina Liquid Chemistries Corp.
Sources (1)
- FDA UDI 8bfb22a4-8825-443d-b077-87d85f465cb3 37 fields · synced May 30, 2026