Ferrozine (Colorimetric) Iron Binding Capacity

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Jilin and Shandong: 2 hold an FDA registration.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer

How Is JMO Classified?

Ferrozine (Colorimetric) Iron Binding Capacity is FDA product code JMO, Class 1, 21 CFR 862.1415.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Process design (2) and Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Ferrozine (Colorimetric) Iron Binding Capacity

Carolina Liquid Chemistries Corp.® Uibc Unsaturated Iron Binding Capacity CC660

UIBC (Unsaturated Iron Binding Capacity) w/ cal 2 x 100 tests

Ferrozine (Colorimetric) Iron Binding Capacity

K-Assay® Uibc Calibrator

For the calibration of the K-ASSAY® UIBC assay.

Ferrozine (Colorimetric) Iron Binding Capacity

Vitros

VITROS Chemistry Products dTIBC Reagent

Ferrozine (Colorimetric) Iron Binding Capacity

K-Assay® Uibc Reagent (L)

For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.

Ferrozine (Colorimetric) Iron Binding Capacity

Iron (Fe)

2 catalogue numbers from SI8049, listed by Randox Laboratories Limited, United Kingdom, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.

Ferrozine (Colorimetric) Iron Binding Capacity

Total-Iron Binding Capacity (Tibc)

2 catalogue numbers from TI1010, listed by Randox Laboratories Limited, United Kingdom, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.

Ferrozine (Colorimetric) Iron Binding Capacity

Atellica CH Tibc

Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T

Ferrozine (Colorimetric) Iron Binding Capacity

Pointe Direct Tibc Reagent

Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers.…

Ferrozine (Colorimetric) Iron Binding Capacity

K-Assay® Uibc Reagent

For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.

Ferrozine (Colorimetric) Iron Binding Capacity

Advia® Chemistry Tibc Total Iron Binding Capacity Reagents

IBCT - ADVIA Chem. - RGT - 4x100/4x80 tests

Ferrozine (Colorimetric) Iron Binding Capacity

Dimension Vista® Flex® Reagent Cartridge Tibc

Total Iron Binding Capacity Flex® reagent cartridge, 160 Tests

Ferrozine (Colorimetric) Iron Binding Capacity

ACE

Direct Total Iron-Binding Capacity (TIBC) Reagent

Ferrozine (Colorimetric) Iron Binding Capacity

Uibc

The product is intended for the quantitative in vitro determination of Iron/UIBC in serum.

Ferrozine (Colorimetric) Iron Binding Capacity

ClearChem Diagnostics Inc. TIBC-Direct

In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL

Ferrozine (Colorimetric) Iron Binding Capacity

Synermed®

UIBC Binding Buffer Reagent 6 X 490 mL _ 6 X 10 mL

Ferrozine (Colorimetric) Iron Binding Capacity

Total Iron-Binding Capacity 2 (TIBC_2)

A TIBC_2 test system is a device intended for the quantitative in vitro determination of total iron-binding capacity (TIBC) concentration in serum.

Ferrozine (Colorimetric) Iron Binding Capacity

Pointe Scientific, Inc.

Direct Total Iron-Binding Capacity (TIBC), for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Size: 1 x…

Ferrozine (Colorimetric) Iron Binding Capacity

Uibc-SL

4 catalogue numbers from 153-50, listed by Sekisui Diagnostics, LLC, United States, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.

Ferrozine (Colorimetric) Iron Binding Capacity

Dimension® Flex® Reagent Cartridge Ibct

Total Iron Binding Capacity Flex® reagent cartridge, 240 tests

Ferrozine (Colorimetric) Iron Binding Capacity

Synchron

SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit

Ferrozine (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.

Ferrozine (Colorimetric) Iron Binding Capacity

Pointe Scientific, Inc. Direct Tibc

Direct TIBC Reagent is for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. 1 x 60ml, 1 x 20ml

Ferrozine (Colorimetric) Iron Binding Capacity

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.

Ferrozine (Colorimetric) Iron Binding Capacity

Fe

The product is an in vitro diagnostic test intended for the quantitative determination of Iron in serum

Ferrozine (Colorimetric) Iron Binding Capacity

Iron (Fe) Reagent Kit

Iron Reagent Kit for use with EasyRA Analyzers

Ferrozine (Colorimetric) Iron Binding Capacity

Teco Diagnostics Iron/TIBC Reagent Set

Teco Diagnostics Iron/TIBC Reagent Set is used for the quantitative determination of iron, total iron-binding capacity in human serum.

Ferrozine (Colorimetric) Iron Binding Capacity

Biobase

3 catalogue numbers from R1:20mL×1 R2:5mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.

Ferrozine (Colorimetric) Iron Binding Capacity

Pointe Tibc Reagent

Pointe TIBC Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 8 x 20ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers.…

Ferrozine (Colorimetric) Iron Binding Capacity

AU

Uibc

Ferrozine (Colorimetric) Iron Binding Capacity

Direct Tibc Reagent

For use in the determination of total iron-binding capacity in serum on the Mindray BS-480 analyzer. For in vitro diagnostic use only. 4 x 60ml, 4 x 36ml

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