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IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref IS-4400Ref CL2701Model 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

by Immunodiagnostic Systems Limited

Identity

Trade Name
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) EUDAMED
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) FDA UDI
Generic Name
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) EUDAMED
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
IS-4400 EUDAMEDFDA UDI
2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2 EUDAMED
CL2701 EUDAMED

Identifiers

Primary DI / UDI-DI
05060169690301 EUDAMEDFDA UDI
06942028508752 EUDAMED
Basic UDI-DI
B-05060169690301 EUDAMED
B-06942028508752 EUDAMED
FDA Product Code
CFL FDA UDI
EMDN Code
W0102060405 INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1 EUDAMED
W0102060406 INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 EUDAMED
GMDN Term
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1370 FDA UDI
Market of Registration
Belgium EUDAMED
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMEDEUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunodiagnostic Systems Limited
EUDAMED SRN
GB-MF-000015851
Authorised Representative
Immunodiagnostic Systems SA BE-AR-000015342

Sources (3)

  • EUDAMED 6b5a75f5-46b7-4475-a55e-41c952808db7 61 fields · synced Jul 29, 2026
  • FDA UDI 4ecf0f79-b4d9-4cb3-96ad-b34895c01280 34 fields · synced May 30, 2026
  • EUDAMED a5ad18df-e9e5-46bf-b699-1a8c7dbf8f27 61 fields · synced Jul 29, 2026