Iron (Total)

2 catalogue numbers from 102-25, listed by Sekisui Diagnostics, LLC, United States, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code JMO
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Record

Regulatory record for Iron (Total)
Listed by Sekisui Diagnostics, LLC, United States
FDA product code JMO
Device type Ferrozine (Colorimetric) Iron Binding Capacity
Device class Class 1
Regulation 21 CFR 862.1415
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2016-09-20
Record revised 2026-06-30 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Distribution end date 2019-07-08

Catalogue Numbers

Catalogue numbers for Iron (Total)
Catalogue number Size Status
102-25 Withdrawn
102-15 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Synermed® Infrared Laboratory Systems LLC 5
Fe Randox Laboratories Limited 4
Uibc-SL Sekisui Diagnostics, LLC 4
Biobase Biobase Biodustry(Shandong)Co., Ltd. 3
Synchron Beckman Coulter, Inc. 3
Total Iron-Binding Capacity 2 (TIBC_2) Randox Laboratories Limited 3
Pointe Scientific, Inc. Horiba Instruments Incorporated 2
K-Assay® Uibc Reagent Kamiya Biomedical Company LLC 2
Total-Iron Binding Capacity (Tibc) Randox Laboratories Limited 2
Iron (Fe) Randox Laboratories Limited 2
Direct Tibc Reagent Medtest DX 1
AU Beckman Coulter, Inc. 1

Showing 12 of 29. All products under Ferrozine (Colorimetric) Iron Binding Capacity

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer