Detergent

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Guangxi and Jilin, and 2 other provinces.

B&E BIO-Technology Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Infitek Co., Ltd. Shanghai
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer

How Is JCB Classified?

Detergent is FDA product code JCB, Class 1, 21 CFR 864.4010.

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. It is also exempt from most of the quality system regulation.

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 cause the FDA records most often is Material/Component Contamination (1).

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

Carolina Liquid Chemistries Corp.® Alkaline Wash Solution DT160

Alkaline Wash Solution (ALK)

Atellica DT Solution 4 (S4)

Atellica DT Solution 4 (S4) is used for the automatic decontamination and cleaning of cuvettes after each use and for the removal of any reagent, blood component, urine or CSF and…

Diatro•Hypoclean CC

Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution for intensive oxidative cleaning, rinsing and washing of…

Micro-Scientific Enzyclean II

MS Enzyclean II 4X1G

Atellica DT Solution 1 (S1)

Atellica DT Solution 1 (S1) contains stabilized and micro- filtered hypochlorite and detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s probes, cuvettes, and tubings…

Coulter AcT Rinse Shutdown Diluent

Catalogue number 8448350, listed by Beckman Coulter, Inc., United States, under Detergent. 5 manufacturers in China are registered for this product code.

Atellica DT Solution 2 (S2)

Atellica DT Solution 2 (S2) contains detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s probes, cuvettes, and tubings removing reagents, samples and protein deposits.

Flow Clean

Flow Clean Cleaning Agent

MR Detergent Solution

Catalogue number 105-011383-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

5x TBS Wash Buffer

The product is intended as a wash buffer for the chemiluminescence reaction in the fully automated chemiluminescence immunoassay analyzer KleeYa®.

Cleaning Solution

Cleaning kit contains stabilized and micro-filtered hypochlorite and detergents, for regular cleaning and rinsing of clinical chemistry analyzers’ probes, cuvettes, and tubings removing…

Advia 120/2120/2120i Aspiration Pathway Wash Kit

Catalogue number 11306490, listed by Siemens Healthcare Diagnostics Inc, United States, under Detergent. 5 manufacturers in China are registered for this product code.

Advia 120/212-/2120i Perox Flow Cell Wash Kit

ADVIA 120/2120/2120i Perox Flow Cell Wash Kit

Advia 120/2120/2120i Vent Line Wash Kit

Catalogue number 11306492, listed by Siemens Healthcare Diagnostics Inc, United States, under Detergent. 5 manufacturers in China are registered for this product code.

SpecClean Ultrasonic Cleaner Solution

SpecClean Ultrasonic Cleaner Solution Gallon

CLC Fast Detergent 1 Alkaline Washing Solution 100263

Alkaline Wash Solution (ALK)

M-30R

Catalogue number M-30R, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Micro-Scientific MicroKleen LS

MS Microkleen-LS 4X1G

Aquios

AQUIOS Sodium Hypochlorite Solution

DxH 500 Series Cleaner

Catalogue number B36868, listed by Beckman Coulter Ireland Inc, Ireland, under Detergent. 5 manufacturers in China are registered for this product code.

Good Vibrations

Good Vibrations 55 Gallon Drum

Phoenix Diagnostics

Fast Detergent 1 for Tokyo Boeki BiOLiS Series Chemistry Systems

Micro-Scientific MicroKleen HS

MS Microkleen-HS 4X1G

Detergent for Automatic Urine Analyzer

3 catalogue numbers from URIT D21,5L, listed by Urit Medical Electronic Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Grifols Wash Solution A

Grifols Wash Solution A is used for internal washing of the Grifols analyzer's fluidic system. The solution must be diluted prior to use.

Additive for Wash Solution

Wash solution additive contains concentrated detergents, for regular cleaning and rinsing of clinical chemistry analyzers’ probes, cuvettes, and tubings removing reagents, samples and…

Coulter Ac•T 5diff Rinse

COULTER AcT 5diff Rinse 1 L

DG Clean

DG Clean is a solution for cleaning the probes of Grifols analyzers.

Atellica DT Solution 3 (S3)

Atellica DT Solution 3 (S3) contains concentrated detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s probes, cuvettes, and tubings removing reagents, samples and…

DxU

DxU Detergent Ready to Use

M-30P

Catalogue number M-30P, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Carolina Liquid Chemistries Corp.® Probe Rinse CC735

Probe Rinse

Ac•T Rinse Shutdown Diluent

Ac•T Rinse Shutdown Diluent (500 ml)

Advia 120/2120/2120i RBC Flow Cell Wash Kit

Catalogue number 10734561, listed by Siemens Healthcare Diagnostics Inc, United States, under Detergent. 5 manufacturers in China are registered for this product code.

Probe Cleanser

2 catalogue numbers from PROBE CLEANSER, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Detergent Concentrated

Catalogue number DxU,1×500mL, listed by Urit Medical Electronic Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Detergent Ready to Use

Catalogue number DxU,1×5L, listed by Urit Medical Electronic Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

MR Buffer Solution

Catalogue number 105-011382-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Detergent. 5 manufacturers in China are registered for this product code.

Diatro•Cleaner

Diatro•Cleaner cleaning reagent is a stabilized and microfiltered detergent solution for regular automated cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and…

Coulter Clenz Cleaning Agent

COULTER CLENZ Cleaning Agent (500ml)

Grifols Wash Solution B

Grifols Wash Solution B is used for internal washing of the Grifols analyzer's fluidic system. The solution must be diluted prior to use.

Cell-DYN

CELL-DYN Emerald 22 Easy Cleaner

LH Series Cleaner

LH Series Cleaner (10L)

Phoenix Diagnostics, Inc.

Alkaline Wash for Tokyo Boeki BiOLiS 50i Series Electrolyte Systems

Micro-Scientific Enzyclean II LS

MS Enzyclean II LS 4X1G

Neodisher® GK

Cleaning agent for laboratory use

ET Foam

ET Foam - 200 liter drum

Micro-Scientific Enzyclean IV

MS Enzyclean IV 4X1G

Cuvette Cleaner Solutions

Cleaning kit contains stabilized and micro-filtered hypochlorite and detergents, for regular cleaning and rinsing of clinical chemistry analyzers’ probes, cuvettes, and tubings removing…

Drew Scientific

DREW D3 ENZYMATIC CLEANER- Bulk Liquid

Carolina Liquid Chemistries Corp.® Wash Concentrate ST160

CX3 Wash Concentrate (CX3Wash)

Surgical Milk

Surgical Milk - 1000 liter tote

Carolina Liquid Chemistries Corp.® Wash Solution AU-2000

Wash Solution (AU400/480/640/680 Wash)

Micro-Scientific Enzyclean

MS Enzyclean LS 4X1G

Boule EasyCleaner

Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system

Coulter DxH Cleaner

COULTER DxH Cleaner (10L)

JAS Diagnostics

ABS Olympus Wash Solution - Concentrated (5 X 4L)

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