System, Test, Beta-2-Microglobulin Immunological

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Hebei, Jilin and Shandong.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei

How Is JZG Classified?

System, Test, Beta-2-Microglobulin Immunological is FDA product code JZG, Class 2, 21 CFR 866.5630.

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 6 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Device Design (1), Environmental control (1) and Nonconforming Material/Component (1).

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

System, Test, Beta-2-Microglobulin Immunological

Human Beta-2 Microglobulin Kit for Use on the Spaplus

Catalogue number LK043.S, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Beta-2 Microglobulin Elisa

The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microglobulin in human serum.

System, Test, Beta-2-Microglobulin Immunological

Human Beta-2 Microglobulin Urine Kit for Use on the Spaplus

Catalogue number LK043.U.S, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Alinity

Alinity c B2-Microglobulin Reagent Kit 200 Tests

System, Test, Beta-2-Microglobulin Immunological

Beckman Coulter Beta-2-Microglobulin Kit

Catalogue number A09445, listed by Agilent Technologies Singapore (International) Pte Ltd., Singapore, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Atellica CH B2M

ß2-Microglobulin (B2M) Atellica CH - RGT 400T

System, Test, Beta-2-Microglobulin Immunological

AIA-Pack BMG Calibrator Set

AIA-Pack BMG Calibrator Set: 1 catalogue number listed by Tosoh Corp., Japan, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

K-Assay® Beta-2 Microglobulin Urine Calibrator

For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.

System, Test, Beta-2-Microglobulin Immunological

ST AIA-Pack BMG

ST AIA-Pack BMG: 1 catalogue number listed by Tosoh Corp., Japan, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

AU

β-2 Microglobulin

System, Test, Beta-2-Microglobulin Immunological

Immulite® 2000 Systems BMG Beta-2 Microglobulin

b2 Microglobulin - IMMULITE - RGT - 200 Tests

System, Test, Beta-2-Microglobulin Immunological

Beta-2 Microglobulin Elisa

The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microglobulin in human serum.

System, Test, Beta-2-Microglobulin Immunological

Β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method): 1 catalogue number listed by Medicalsystem Biotechnology Co., Ltd., China, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

K-Assay® Beta-2 Microglobulin Serum / Plasma Calibrator

For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.

System, Test, Beta-2-Microglobulin Immunological

Immulite® / Immulite® 1000 Systems BMG Beta-2 Microglobulim

b2 Microglobulin - IMMULITE - RGT - 100 Tests

System, Test, Beta-2-Microglobulin Immunological

Human Beta-2 Microglobulin Latex Kit for Use on the Siemens Bn™ii

Catalogue number LK043.T, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

AIA-Pack BMG Sample Diluting Solution

AIA-Pack BMG Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

K-Assay® Beta-2 Microglobulin Reagent

For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay.

System, Test, Beta-2-Microglobulin Immunological

Poly Rb A-Hu Beta-2-Microglobulin

Polyclonal Rabbit Anti-Human Beta-2-Microglobulin

System, Test, Beta-2-Microglobulin Immunological

Immulite® Systems BMG Control Beta-2 Microglobulin

B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL

System, Test, Beta-2-Microglobulin Immunological

B2Microglobulin (B2M)

2 catalogue numbers from BM3887, listed by Randox Laboratories Limited, United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Human Beta-2 Microglobulin Nanorid Radial Immunodiffusion Kit

Catalogue number GT043.3, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Immulite/Immulite 1000 Systems Beta-2-Microglobulin Sample Diluent

Beta 2 Microglobulin Sample Diluent - IMMULITE - 1x100mL

System, Test, Beta-2-Microglobulin Immunological

Beta-2 Microglobulin Elisa

The Beta-2 Microglobulin ELISA is intended for use in the quantitative determination of beta-2-microglobulin in human serum.

System, Test, Beta-2-Microglobulin Immunological

Optilite Beta 2 Microglobulin Urine Kit

Catalogue number LK043.L.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Dimension Vista® SS2-Microglobulin Flex® Reagent Cartridge

For the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista System

System, Test, Beta-2-Microglobulin Immunological

Tina-Quant SS2-Microglobulin

2 catalogue numbers from 08047499190, listed by Roche Diagnostics Gmbh, Germany, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

N A1-Microglobulin Kit

Quantitative determination of a1-microglobulin in human urine on BN Systems

System, Test, Beta-2-Microglobulin Immunological

Optilite® Beta-2 Microglobulin Kit

Catalogue number LK043.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

N Latex SS2-Microglobulin

Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Systems

System, Test, Beta-2-Microglobulin Immunological

Biobase

11 catalogue numbers from R1:40mL×3 R2:20mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Advia® Chemistry B2M SS2-Microglobulin Reagents

ADVIA Chemistry B2M reagents measure beta-2-microglobulin in human serum or lithium-heparin or potassium-EDTA plasma on the ADVIA 1650 system. The assay aids diagnosis of active rheumatoid…

System, Test, Beta-2-Microglobulin Immunological

Tinaquant 2microglobulin

3 catalogue numbers from 11660551216, listed by Roche Diagnostics Gmbh, Germany, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.

System, Test, Beta-2-Microglobulin Immunological

Which Manufacturers in China Make This?

How Is JZG Classified?

How Does It Reach the US Market?

What Has Gone Wrong With It?

Where China Actually Supplies