Device, Automated Sedimentation Rate

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, based in Shandong and Guangdong.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Labpeak Co., Ltd. Shandong
Scitek Global Co., Ltd. Shandong
Shenzhen Yhlo Biotech Co., Ltd. Guangdong

What Is FDA Product Code GKB?

Device, Automated Sedimentation Rate is FDA product code GKB, Class 1, 21 CFR 864.5800.

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 2022. None was by a company in China. The root causes the FDA records most often are Labeling Change Control (2) 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.

Device, Automated Sedimentation Rate

ZBT-ESR

Automated Erythrocyte sedimentation rate analyser

Device, Automated Sedimentation Rate

Microsed-System® Automated ESR Analyzer

The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human…

Device, Automated Sedimentation Rate

VES-Matic 5

Catalogue number 10360, listed by Diesse Diagnostica Senese SPA, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

miniiSED

Catalogue number 112-01017, listed by Alcor Scientific LLC, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte® ESR Non-Vacuum Tubes, Carton

Catalogue number EX-50100, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Mix-Rate® X20 Automated ESR Analyzer

The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human…

Device, Automated Sedimentation Rate

Biobase

Catalogue number BK-ESR40, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

TEST1 BCL

Catalogue number TEST1 BCL, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Cube 30 Touch

Catalogue number 10395, listed by Diesse Diagnostica Senese SPA, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte® ESR Vacuum Tube

2 catalogue numbers from EP-10605-H1, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

ESR-10 Manual Rack

A 10-position manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes.

Device, Automated Sedimentation Rate

Excyte® ESR Vacuum Tubes, Carton

Catalogue number EX-50205, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte

Automated ESR Analyzer (erythrocyte sedimentation rate)

Device, Automated Sedimentation Rate

Monosed® ESR Vacuum Tubes, Carton

2 catalogue numbers from PRD-PRV11V-H12, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte® ESR Vacuum Tubes

Catalogue number EX-50205, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

TEST1 SDL

Catalogue number TEST1 SDL, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Roller 10 Plus Needle

Catalogue number ROLLER 10 PLUS NEEDLE, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

ESR Stat 6

Catalogue number ESR STAT 6, listed by AirScan, Inc., United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Starrsed Saline

Product for automatic cleaning of Starrsed ESR analyzers

Device, Automated Sedimentation Rate

VES-Matic Original

Catalogue number 10340, listed by Diesse Diagnostica Senese SPA, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte 20

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

Device, Automated Sedimentation Rate

Sediplus® S 2000 NX

2 catalogue numbers from 90.1092, listed by Sarstedt Aktiengesellschaft & Co.KG, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Starrsed Rinse Solution

Product for automatic rinsing of pipettes in Starrsed ESR analyzers

Device, Automated Sedimentation Rate

Roller 20

2 catalogue numbers from ROLLER 20, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Mini-Cube

Catalogue number 10392, listed by Diesse Diagnostica Senese SPA, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

TEST1 YDL

Catalogue number TEST1 YDL, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Latex Controls

4 catalogue numbers from LATEX CONTROLS, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Sediplus® S 200, 12 V DC

Catalogue number 90.189.900, listed by Sarstedt Aktiengesellschaft & Co.KG, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

iSED

Catalogue number 112-00101, listed by Alcor Scientific LLC, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Latex EQE (2 Test)

3 catalogue numbers from LATEX EQE (2 TEST), listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte® ESR Non-Vacuum Tubes

Catalogue number EX-50100, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

TEST1 XDL

Catalogue number TEST1 XDL, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

TEST1 THL

TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors.

Device, Automated Sedimentation Rate

ESR-Auto Plus

A 10-position automated sed-rate analyzer.

Device, Automated Sedimentation Rate

JO-Plus

Catalogue number JO-PLUS, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Starrsed Cleaning Agent

Product for cleaning pipettes in Starrsed ESR analyzers

Device, Automated Sedimentation Rate

TEST1 MDL

Catalogue number TEST1 MDL, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Starrsed Disinfectant

Product for automatic disinfection of the waste system of Starrsed ESR analyzers

Device, Automated Sedimentation Rate

Starrsed X-Clean

Product for automatic cleaning of pipettes in Starrsed ST

Device, Automated Sedimentation Rate

TEST1 2.0

Catalogue number TEST1 2.0, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Vision ESR Analyzer

Constraint

Device, Automated Sedimentation Rate

iSED Elite

Catalogue number 112-00222, listed by Alcor Scientific LLC, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Monosed® ESR Vacuum Tubes

Catalogue number PRD-PRV11B-50, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte®

Excyte®: 4 catalogue numbers listed by ELITechGroup B.V., under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Excyte® ESR Vacuum Tube, Carton

2 catalogue numbers from EP-10605, listed by ELITechGroup Inc, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

Device, Automated Sedimentation Rate

Starrsed Control

Control blood for Starrsed Instruments and procedures

Device, Automated Sedimentation Rate

Starrsed

Semi-automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity with the Westergren standard.

Device, Automated Sedimentation Rate

Latex Calibrators

2 catalogue numbers from LATEX CALIBRATORS, listed by Alifax SRL, Italy, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.

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