Who else makes this device?

Name: Unsaturated Iron-Binding Capacity
Brand: Unsaturated Iron-Binding Capacity

Clinical Chemistry › Test SystemsFerrozine (Colorimetric) Iron Binding Capacity

Unsaturated Iron-Binding Capacity

Catalogue number 08058776190, listed by Roche Diagnostics Gmbh, Germany, 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

1catalogue number

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 Unsaturated Iron-Binding Capacity
Listed by	Roche Diagnostics Gmbh, Germany
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, Manufacturer, Exporter
Record published	2020-03-05
Record revised	2020-11-11 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2020-10-28

Catalogue Numbers

Catalogue numbers for Unsaturated Iron-Binding Capacity
Catalogue number	Size	Status
08058776190		Withdrawn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
Iron (Total)	Sekisui Diagnostics, LLC	2
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

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.