Identity
- Trade Name
- IDS-iSYS 25 VitDS Control Set FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
- Model / Reference
- IS-2530 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690752 FDA UDI
- 510(k) Number
- K161831 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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, control
IDS-iSYS 25 VitDS Control Set by Immunodiagnostic Systems , Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, control.
- PreciControl Vitamin D total III — Roche Diagnostics Corp. · Class I
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- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 — Carolina Liquid Chemistries Corp. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- Method Verification Kit - Vitamin D — QUALIGEN INC. · Class I
- Atellica IM VitD MCM — Siemens Healthcare Diagnostics · Class I
- Diazyme — Diazyme Laboratories, Inc.
- Alinity — ABBOTT IRELAND · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (2)
- FDA UDI 708a545b-0cfc-446c-bd35-2a07eca0e433 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026