Identity
- Trade Name
- ISE Solution 1 FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Model / Reference
- 20738050122 FDA UDI
Identifiers
- Catalog Number
- 20738050122 FDA UDI
- Primary DI / UDI-DI
- 04015630915071 FDA UDI
- 510(k) Number
- K963627 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
No
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: Multiple-type clinical chemistry analyte profile IVD, calibrator
ISE Solution 1 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963627 also covers:
- Chloride Electrode — Roche Diagnostics Corp.
- ISE Potassium Electrode — Roche Diagnostics Corp.
- ISE Solution 2 — Roche Diagnostics Corp.
- ISE Solution 3 — Roche Diagnostics Corp.
- ISE Standard High — Roche Diagnostics Corp.
- ISE Standard Low — Roche Diagnostics Corp.
- Lithium Electrode — Roche Diagnostics Corp.
- Potassium Electrode — Roche Diagnostics Corp.
- Sodium Electrode — Roche Diagnostics Corp.
- no MS ISE Calibrator Direct) — Roche Diagnostics Corp.
- no MS ISE Calibrator IndirectUrine) — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 3c63861b-661e-43ec-b1b0-10e1f1d5b378 35 fields · synced May 30, 2026