← Back to catalogue

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

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
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
Model / Reference
5 tests/kit FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369205 FDA UDI
FDA Product Code
OAM FDA UDI
GMDN Term
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1550 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

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 — FDA UDI — listed…

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • FDA UDI 07b7e533-b403-4b8b-8edb-18abc29b2079 32 fields · synced May 30, 2026