Identity
- Trade Name
- AU FDA UDI
- Generic Name
- Multiple electrolyte IVD, control FDA UDI
- Device Name
- ISE Internal Reference Solution FDA UDI
- Model / Reference
- AUH1017 FDA UDI
- Description
- ISE Internal Reference Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590140014 FDA UDI
- FDA Product Code
- JGS FDA UDI
- GMDN Term
- Multiple electrolyte IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 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
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
Yes
FDA UDI
Category: Multiple electrolyte IVD, control
Au by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, control.
- Sweat Control Level 1, 2, & 3 Set 9x3mL — QUANTIMETRIX CORP. · Class I
- ChemSTAT Hematocrit Evaluator 1 — INSTRUMENTATION LABORATORY COMPANY · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class I
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class I
- GEM ChemSTAT critPVP 1-4 — INSTRUMENTATION LABORATORY COMPANY · Class II
- ChemSTAT Hematocrit Evaluator 3 — INSTRUMENTATION LABORATORY COMPANY · Class II
- ChemSTAT Hematocrit Evaluator 2 — INSTRUMENTATION LABORATORY COMPANY · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI f9b86937-3d02-4e16-babe-7f1895e4b70a 33 fields · synced Jun 8, 2026