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IDS-iSYS Aldosterone Calibration Verifiers
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K142994
Identity
- Trade Name
- IDS-iSYS Aldosterone Calibration Verifiers FDA UDI
- Generic Name
- Aldosterone IVD, calibrator FDA UDI
- Model / Reference
- IS-3335 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690967 FDA UDI
- 510(k) Number
- K142994 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Aldosterone IVD, calibrator 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: Aldosterone IVD, calibrator
IDS-iSYS Aldosterone Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142994 | Class I | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (2)
- FDA UDI 0fedc089-3894-499a-98a2-bdc390d3e9f4 59 fields · synced Jun 18, 2026
- FDA 510(k) K142994 1 fields · synced Jun 9, 2026