Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Which Manufacturers in China Make This?

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

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Getein Biotech, Inc. Jiangsu

What Is FDA Product Code KLI?

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine is FDA product code KLI, Class 2, 21 CFR 862.1700.

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 Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Device Design (2) and Vendor change control (1).

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

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total Thyroxine Elisa (Total T4 Elisa)

The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis…

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total Thyroxine (T4) Elisa

For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

QMedix™

QMedix™T4 ELISA Kit This test is intended to quantitatively detect total thyroxine (T4) associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Pointe Scientific, Inc.

T4 for the quantitative determination of the Total Thyroxine (T4) concentration in human serum. For in vitro diagnostic use only. 96 Test

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Dimension Vista® Flex® Reagent Cartridge T4

Thyroxine Flex® reagent cartridge, 160 tests

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Immulite®/Immulite® 1000 Systems T4 Sample Diluent

Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Free Thyroxine (Ft4) Elisa

The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

T4 High Sensitivity AccuBind Elisa Test System – 96 Wells

Catalogue number 12825-300, listed by Monobind, Inc., United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

T4 High Sensitivity AccuBind Elisa Test System – 192 Wells

Catalogue number 12825-300, listed by Monobind, Inc., United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Immulite®/Immulite® 1000 Systems T4 Total T4

T4 Total - IMMULITE - RGT - 500 Tests

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Alinity

Alinity i Total T4 Reagent Kit 1200 Tests

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Vidas® T4

The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat ion of human thyroxine (T4) concentration in serum or plasma (heparin).

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total Thyroxine (Tt4) Elisa

Catalogue number EIA-5279, listed by DRG International, Inc., United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Vitros

VITROS Immunodiagnostic Products Total T4 Reagent Pack

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

AccuDiag ™

AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concentration in human serum.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

GSP Neonatal Thyroxine (T4) Kit

For the quantitative determination of thyroxine (T4) in dried blood.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Spotcheck

T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroxine (T4) Levels in Neonates

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Access Total T4 II

The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the…

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

AIA-Pack T4 Sample Diluting Solution

AIA-Pack T4 Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Immulite® 2000 Systems TT4 Total T4

T4 Total - IMMULITE - RGT - 200 Tests

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Architect

ARCHITECT Total T4 Reagent Kit (2000T)

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

DRI Thyroxine (T4)

2 catalogue numbers from 0454, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Free Thyroxine (Ft4) Elisa

The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total T4 Thyroxine)

Catalogue number 20739006322, listed by Roche Diagnostics Gmbh, Germany, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

ST AIA-Pack T4

ST AIA-Pack T4: 1 catalogue number listed by Tosoh Corp., Japan, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

AIA-Pack T4 Calibrator SET

AIA-Pack T4 Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Cedia T4 Assay

Catalogue number 100050, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

ACE

T4 Reagent

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total Thyroxine (Tt4) Elisa

Catalogue number EIA-5279, listed by DRG Instruments Gesellschaft mit beschränkter Haftung, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Access Total T4

The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the…

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Total Thyroxine (T4) Elisa

For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

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