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Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref IGF-5C1

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Identity

Trade Name
Insulin-like Growth Factor-binding Protein 1 (iGFBP-1) Test EUDAMED
Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr FDA UDI
Generic Name
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Insulin-like Growth Factor-binding Protein 1 (iGFBP-1) Test EUDAMED
Model / Reference
IGF-5C1 EUDAMED
20 tests/kit FDA UDI

Identifiers

Primary DI / UDI-DI
D-IGF-5C1QG EUDAMED
06974849369212 FDA UDI
Basic UDI-DI
B-IGF-5C1QG EUDAMED
FDA Product Code
OAM FDA UDI
EMDN Code
W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
GMDN Term
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1550 FDA UDI
Market of Registration
Germany 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

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Category: Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical

Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — IVDD, FDA UDI…

Similar devices

Also classified as Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Sources (2)

  • FDA UDI c966e18e-5b88-49c7-b961-e00ff12535a1 32 fields · synced Sep 30, 2026
  • EUDAMED c406328a-3351-4427-a82b-35eac9cf3fa1 61 fields · synced Sep 17, 2026