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IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 FDA UDI
Generic Name
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
IGF BP3 - IMMULITE - RGT - 100 Tests FDA UDI
Model / Reference
10381425 FDA UDI
Description
IGF BP3 - IMMULITE - RGT - 100 Tests FDA UDI

Identifiers

Catalog Number
LKGB1 FDA UDI
Primary DI / UDI-DI
00630414966298 FDA UDI
FDA Product Code
CFL FDA UDI
GMDN Term
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1370 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

No

FDA UDI

Category: Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 6dcd83cf-bfb8-46ee-98f9-64c1239e2c9a 36 fields · synced May 30, 2026