Identity
- Trade Name
- ISE ELECTROLYTE REFERENCE 88811 FDA UDI
- Generic Name
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
- Device Name
- ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL FDA UDI
- Model / Reference
- 88811 FDA UDI
- Description
- ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL FDA UDI
Identifiers
- Catalog Number
- 88811 FDA UDI
- Primary DI / UDI-DI
- 00817302020670 FDA UDI
- FDA Product Code
- CEM FDA UDICGZ FDA UDIJFP FDA UDIJGS FDA UDIJFL FDA UDI
- GMDN Term
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1170 FDA UDI862.1145 FDA UDI862.1665 FDA UDI862.1160 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2000 Milliliter FDA UDI
Category: Ion selective electrode (ISE) reference solution IVD, reagent
Ise Electrolyte Reference 88811 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 2a07163a-ff4c-45d1-821d-71368a6160b8 37 fields · synced May 31, 2026