Identity
- Trade Name
- IDS-iSYS 25 VitDS FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
- Model / Reference
- IS-2500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690622 FDA UDI
- 510(k) Number
- K161831 FDA UDI
- FDA Product Code
- MRG FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1825 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
Category: Multiple form 25-hydroxy Vitamin D IVD, reagent
IDS-iSYS 25 VitDS by Immunodiagnostic Systems , Ltd. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, reagent.
- LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers — Diasorin Inc.
- Diazyme — Diazyme Laboratories, Inc.
- ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set — CLEARCHEM DIAGNOSTICS INC. · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- LIAISON® 25 OH Vitamin D TOTAL Assay Specimen Diluent — Diasorin Inc.
- Diazyme — Diazyme Laboratories, Inc.
- ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Kit — CLEARCHEM DIAGNOSTICS INC. · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K161831 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (2)
- FDA UDI ca8bef00-d04c-4704-9ebf-9c8fcbff5158 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026