Calibrator, Secondary

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Jiangsu, contract manufacturer

How Is JIT Classified?

Calibrator, Secondary is FDA product code JIT, Class 2, 21 CFR 862.1150.

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 55 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (8), Storage (5) and Software design (4).

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

Calibrator, Secondary

Dimension/Vista Lipase Calibrator

Catalogue number 11538127, listed by Siemens Healthcare Diagnostics Inc, United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Fruc CAL

This product is intended for in vitro diagnostic use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Calibrator, Secondary

ACE

KIT, Direct Tibc Calibrator

Calibrator, Secondary

Elecsys FSH CalSet II

Catalogue number 3032680122, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Atellica CH Fruc Calibrator

Fructosamine (Fruc) Calibrator Atellica CH - CAL 3 x 1.0mL

Calibrator, Secondary

Lumipulse G 25-OH Vitamin D Calibrators

Catalogue number 234020, listed by Fujirebio Inc., Japan, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

DImension Vista® C1 Inhibitor Calibrator

For the calibration of the C1IN method on the Dimension Vista® System

Calibrator, Secondary

CalSet proBNP II

Catalogue number 07360886190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

ISE Calibrator Low

ISE Calibrator Low for Biotecnica Targa 3000,3000+

Calibrator, Secondary

Coagulation Calibrator (Coag CAL)

Catalogue number CG5037, listed by Randox Laboratories Limited, United Kingdom, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Dimension Vista® Alpi CAL

Alkaline Phosphatase Calibrator, 3 x 1mL

Calibrator, Secondary

Calibrator Diluent

Catalogue number 220-0119, listed by Bio-Rad Laboratories Inc., United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Elecsys PTH CalSet

Catalogue number 11972219122, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Advia® Chemistry Upro Urine Protein Calibrator

Urine Total Protein - ADVIA Chem. - CAL - 3x5mL

Calibrator, Secondary

ST AIA-Pack BNP Calibrator SET

ST AIA-Pack BNP Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Atellica CH A1c_E Calibrator

Enzymatic Hemoglobin A1c (A1c_E) Calibrator Atellica CH - CAL 1 x 5.0 mL, 2 x 2 x 1.0 mL

Calibrator, Secondary

Elecsys Cortisol CalSet

Catalogue number 11875124122, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Whole Blood Calibration Standard

Whole Blood Calibration Standard Glutathione

Calibrator, Secondary

Bilirubin Mid-Range Standard

Catalogue number 9575, listed by Verichem Laboratories, Inc., United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Elecsys hGH CalSet

Elecsys hGH CalSet is a laboratory calibrator for the quantitative Elecsys human growth hormone assay on Elecsys and cobas e immunoassay analysers. It provides two concentration levels for…

Calibrator, Secondary

Dimension® Aldl Calibrator

ALDL Calibrator, 2x3x2ml

Calibrator, Secondary

Lumipulse G Prolactin Calibrators

Catalogue number 230954, listed by Fujirebio Inc., Japan, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

AIA-Pack PA Calbrator SET

AIA-Pack PA Calbrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

CalSet Tacrolimus

Catalogue number 05889065190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

ISE High Standard

To provide calibration points for Na+, K+, and Cl- electrodes.

Calibrator, Secondary

Tg II CalSet

Catalogue number 08991405190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Bilirubin Standard, Level F

Catalogue number 9436, listed by Verichem Laboratories, Inc., United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Advia Centaur® Systems ACS: 180® Systems BNP Calibrator

BNP - CENTAUR - CAL - 2x2x2mL

Calibrator, Secondary

Testosterone II CalSet II

Catalogue number 05202230190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Elecsys PTH Stat CalSet

Catalogue number 4894138190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

CalSet Phospho-Tau (181p) Plasma

Catalogue number 09697896190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.

Calibrator, Secondary

Advia Chemistry Enzymatic Hemoglobin A1c Calibrator

ADVIA A1c_E Calibrator, 1x 3mL

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