Identity
- Trade Name
- Alfa Wassermann FDA UDI
- Generic Name
- Chloride (Cl-) electrode IVD FDA UDI
- Device Name
- Electrode, Chloride FDA UDI
- Model / Reference
- 906178 FDA UDI
- Description
- Electrode, Chloride FDA UDI
Identifiers
- Catalog Number
- 906178 FDA UDI
- Primary DI / UDI-DI
- 00857969006051 FDA UDI
- FDA Product Code
- CGZ FDA UDI
- GMDN Term
- Chloride (Cl-) electrode IVD 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
No
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
No
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-) electrode IVD
Alfa Wassermann by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chloride (Cl-) electrode IVD.
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- i-STAT — Abbott Point of Care Inc. · Class II
- I.S.E. CL — Randox Laboratories, Ltd. · Class II
- ISE Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — DIAMOND DIAGNOSTICS Inc
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
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI c0d9d653-cd02-4488-8e36-32edf03722b2 36 fields · synced Jun 6, 2026