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

EUDAMEDFDA UDIFDA 510(k)

Class IVD General (EU MDR)

Ref IS-4430

by Immunodiagnostic Systems Limited

Identity

Trade Name
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Control Set EUDAMED
IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set FDA UDI
Generic Name
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control FDA UDI
Device Name
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Control Set EUDAMED
Model / Reference
IS-4430 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05060169690318 EUDAMEDFDA UDI
Basic UDI-DI
B-05060169690318 EUDAMED
510(k) Number
K111938 FDA UDI
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
GMDN Term
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Belgium 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

EUDAMED

Animal Tissues

Yes

EUDAMED

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

No

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) Control Set by Immunodiagnostic Systems Limited — Class IVD General — FDA_510K, IVDD — listed…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/IVDD

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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 a89e72e7-dc05-4b01-9167-134307f25e17 61 fields · synced Jun 19, 2026
  • FDA UDI 192ee63d-c973-4607-8e8e-b19486d792c2 35 fields · synced May 30, 2026
  • FDA 510(k) K111938 1 fields · synced Jun 9, 2026