Albumin, Antigen, Antiserum, Control

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Hunan and Jilin.

AVE Science & Technology Co., Ltd. Hunan
Dirui Industrial Co., Ltd. Jilin, contract manufacturer

How Is DCF Classified?

Albumin, Antigen, Antiserum, Control is FDA product code DCF, Class 2, 21 CFR 866.5040.

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 3 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Device Design (1) and Material/Component Contamination (1).

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

Albumin, Antigen, Antiserum, Control

DImension Vista® Microalbumin Flex® Reagent Cartridge

For the quantitative measurement of albumin in human urine on the Dimension Vista® System

Albumin, Antigen, Antiserum, Control

Optilite Low Level Albumin Kit

Optilite Low Level Albumin Kit measures albumin in cerebrospinal fluid, urine and serum using the Binding Site Optilite analyser. The laboratory test aids diagnosis of kidney and intestinal…

Albumin, Antigen, Antiserum, Control

Tinaquant Albumin Gen2

Tina-quant Albumin Gen. 2 is an in vitro assay that measures albumin in human serum, plasma, urine and cerebrospinal fluid. It is used with compatible Roche/Hitachi cobas c systems. Albumin…

Albumin, Antigen, Antiserum, Control

Immage

IMMAGE Immunochemistry Systems ALB Albumin Reagent

Albumin, Antigen, Antiserum, Control

Human Microalbumin Kit for Use on Spaplus

Catalogue number NK032.U.S.A, listed by The Binding Site Group Ltd., United Kingdom, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

ABX Pentra Micro ALB 2 Cal

Catalogue number 1300032565, listed by Horiba ABX SAS, France, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

ABX Pentra Micro Albumin 2 CP

Catalogue number 1300032563, listed by Horiba ABX SAS, France, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Microalbumin Elisa

The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin in samples for limited antibody binding sites on the microplate. After…

Albumin, Antigen, Antiserum, Control

Dimension® Flex® Reagent Cartridge Malb

Microalbumin Flex® reagent cartridge, 80 tests

Albumin, Antigen, Antiserum, Control

Optilite Albumin Kit

Catalogue number NK032.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Vitros

VITROS Chemistry Products mALB Reagent

Albumin, Antigen, Antiserum, Control

Carolina Liquid Chemistries Corp.® Malb Microalbumin CC662

MALB (Microalbumin) 2 x 60 tests

Albumin, Antigen, Antiserum, Control

AU

Urine CSF Albumin

Albumin, Antigen, Antiserum, Control

ABX Pentra Micro-ALB CAL

Catalogue number 1220001966, listed by Horiba ABX SAS, France, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

ABX Pentra Micro Albumin CP

Catalogue number 1220001965, listed by Horiba ABX SAS, France, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

AU

Microalbumin

Albumin, Antigen, Antiserum, Control

N Antiserum to Human Albumin

Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems

Albumin, Antigen, Antiserum, Control

Sirrus® Albumin LiquiColor®

For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Albumin, Antigen, Antiserum, Control

DImension Vista® sALB Flex® Reagent Cartridgespecialty Albumin

For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System

Albumin, Antigen, Antiserum, Control

Atellica CH Urine Albumin (UAlb)

Atellica CH Microalbumin (UAlb) Reagent

Albumin, Antigen, Antiserum, Control

Human Albumin NL Bindarid™ Radial Immunodiffusion Kit

Catalogue number RN032.3, listed by The Binding Site Group Ltd., United Kingdom, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Ualb Reagent Kit

Microalbumin Reagent Kit for use with EasyRA Analyzers

Albumin, Antigen, Antiserum, Control

Albumin Elisa

Catalogue number K 6330, listed by Immundiagnostik, Inc., United States, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Antiserum to Human Albumin

Goat antiserum to Human Albumin

Albumin, Antigen, Antiserum, Control

K-Assay® Microalbumin Reagent

For the quantitative determination of human albumin in urine by immunoturbidimetric assay.

Albumin, Antigen, Antiserum, Control

Carolina Liquid Chemistries Corp.® Malb RGT. KIT AU-662

MALB (Microalbumin) 2 x 100 tests

Albumin, Antigen, Antiserum, Control

Synchron

Microalbumin Reagent (MA 2 x 100)

Albumin, Antigen, Antiserum, Control

Microalbumin

Catalogue number SK252-20, listed by Sekisui Diagnostics, LLC, United States, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Yumizen C1200 Albumin U/CSF

Catalogue number 1300023871, listed by Horiba ABX SAS, France, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Ortho

ORTHO® Bovine Serum Albumin, 22% Protein Concentration, pH 7.2

Albumin, Antigen, Antiserum, Control

Microalbuminuria Kit (Immunoturbidimetric Method)

Microalbuminuria Kit (Immunoturbidimetric Method): 1 catalogue number listed by Medicalsystem Biotechnology Co., Ltd., China, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Human Albumin CSF Kit for Use on Spaplus

Catalogue number NK032.L.S, listed by The Binding Site Group Ltd., United Kingdom, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

JAS Diagnostics

Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL)

Albumin, Antigen, Antiserum, Control

K-Assay® Microalbumin Reagent (L)

For the quantitative determination of human albumin in urine by immunoturbidimetric assay.

Albumin, Antigen, Antiserum, Control

Microalbumin Assay

Catalogue number 252-20, listed by Sekisui Diagnostics, LLC, United States, under Albumin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.

Albumin, Antigen, Antiserum, Control

Albumin LiquiColor®

For the Quantitative Colorimetric Determination of Albumin in Serum or Plasma.

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