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IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers FDA UDI
- Generic Name
- Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, calibrator FDA UDI
- Model / Reference
- IS-3935 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690981 FDA UDI
- 510(k) Number
- K122141 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Insulin-like growth factor binding protein 1 (IGFBP-1) 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: Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, calibrator
IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | 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 2d8c6359-020e-4cb0-a04a-f11276edc0f1 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026