Identity
- Trade Name
- IDS-iSYS 25-Hydroxy Vitamin DS Control Set FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
- Model / Reference
- IS-2730S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690417 FDA UDI
- 510(k) Number
- K140554 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
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
No
FDA UDI
Category: Multiple form 25-hydroxy Vitamin D IVD, control
IDS-iSYS 25-Hydroxy Vitamin DS Control Set by Immunodiagnostic Systems , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple form 25-hydroxy Vitamin D IVD, control.
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- Serum Control — Chromsystems Instruments & Chemicals GmbH · Class I
- 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
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 I | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (1)
- FDA UDI f0380ef5-bcca-48c9-8abb-2cc6828560b8 35 fields · synced Jun 8, 2026