Nitroprusside, Ketones (Urinary, Non-Quant.)

Who Makes This Device Type in China?

17 manufacturers in China hold an FDA registration for this device type, concentrated in Jilin, Zhejiang and Shandong, and 4 other provinces. 3 of them are contract manufacturers, able to build to a buyer’s own specification.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
AVE Science & Technology Co., Ltd. Hunan
B&E BIO-Technology Co., Ltd. Shandong
Changchun Merydi BIO-Tech Co., Ltd. Jilin
Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
Changchun LYZ Technology Co., Ltd. Jilin
Chong Qing Teco Huayi Pharm. Co. Chongqing, contract manufacturer
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
E-Linkcare Meditech Co., Ltd. Zhejiang
Eaglenos Sciences, Inc. Jiangsu
Jilin Hongyi BIO-Tech Co., Ltd. Jilin
Jilin Test BIO-Electron Co., Ltd. Jilin
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer
Vivachek Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Shandong, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is JIN Classified?

Nitroprusside, Ketones (Urinary, Non-Quant.) is FDA product code JIN, Class 1, 21 CFR 862.1435.

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 14 recalls under this product code since 2019. 1 was by a company in China. The root causes the FDA records most often are Storage (3), No Marketing Application (2) and Component change control (1).

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

Nitroprusside, Ketones (Urinary, Non-Quant.)

Aimtab Ketone Tablets

Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Urine Reagent Strips, 1-Parameter, Ketone

Urine reagent strips; 1-parameter; ketone; 100 strips per vial

Nitroprusside, Ketones (Urinary, Non-Quant.)

Easy@Home KetoneTest Strips (100 Test Kit)

Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 100 ct

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site M B-HB Strips

The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Heartscare B-Ketone Test Strips (10pcs/box)

Catalogue number TD-4289, listed by Hearts Bio, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Nitro-Tab Ketone Tablets

Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.

Nitroprusside, Ketones (Urinary, Non-Quant.)

B-Hydroxybutyrate LiquiColor®

For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Blood Ketone Test Strips

Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Ketocoach Meter Only

Catalogue number S11007, listed by Amventurex, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Easy@Home Ketone Test Strips (20 Pack)

Catalogue number EZR-101, listed by Easy Healthcare Corporation, United States, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

One+Step Ketone

100strip / 1 bottle

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site B-HB Controls

STAT-Site® Controls are intended to be used to verify the procedural reliability of the assay for β-hydroxybutyrate using STAT-Site® Mβ-HB Meter and Test Strips.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Ketocoach Blood Ketone Meter

Catalogue number s11006, listed by Amventurex, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Easy@Home KetoneTest Strips (150 Test Kit)

Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 150 ct

Nitroprusside, Ketones (Urinary, Non-Quant.)

Ketocoach Control Solution Level 2

Catalogue number S5800335, listed by Amventurex, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

K-Check

The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Urine Strips

Catalogue number UrineRS-10, listed by Urit Medical Electronic Co., Ltd., China, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

URiSCAN 1 Ketones Strip

Urinalysis dip and read strips for visual. Test for Ketones in urine.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Easy@Home Ketone Test Strips (50 Pack)

Catalogue number EZR-101, listed by Easy Healthcare Corporation, United States, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Bkt SS-Ketone Test Strips (50 Pcs/box)

Catalogue number TD-4279, listed by Adam Lawrence, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site Linearity Check

The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using…

Nitroprusside, Ketones (Urinary, Non-Quant.)

KetoBM

Blood Ketone Monitoring System

Nitroprusside, Ketones (Urinary, Non-Quant.)

KetoBM

Blood Ketone Control Solution - Level 1

Nitroprusside, Ketones (Urinary, Non-Quant.)

Blood Ketone Control solution(Level 3)

Catalogue number CM211, listed by E-Linkcare Meditech Co., Ltd., China, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site M B-HB Code Key

The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Blood Ketone Monitoring System

Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Ketocoach 50 Blood Ketone Test Strips

Catalogue number S5640791, listed by Amventurex, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Nova

Nova MAX Plus Ketone Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Blood Ketone Control solution(Level 2)

Catalogue number CM211, listed by E-Linkcare Meditech Co., Ltd., China, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Biocoach Blood Ketone Test Strips 50 Pack (Foil)

Catalogue number S5640934, listed by Amventurex, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Blood Ketone Control solution(Level 1)

Catalogue number CM211, listed by E-Linkcare Meditech Co., Ltd., China, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Rapid Response

Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes,…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Xper Technology Procheck Witty Procheck Smart B-Ketone Test Strips

Catalogue number TD-4631, listed by Taidoc Technology Corporation, Taiwan, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site M B-HB Analyzer Pack

The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Reli-ON®

Ketone test strips - reagent strips for urinalysis

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site WB B-Ketone Test Strips

The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Lucidplus B-Ketone Test Strips 50 Count

Catalogue number 3100-050, listed by Vidan Diagnostics, LLC, United States, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Clinitek Novus® Automated Urine Chemistry Analyzer

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Precision Xtra

Precision Xtra Blood ß-Ketone Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Nova Max

Nova Max Plus Plus Blood Glucose Monitoring System

Nitroprusside, Ketones (Urinary, Non-Quant.)

SureMediks B-Ketone Test Strips (25pcs/box)

Catalogue number TD-4279D, listed by Rasimo Systems LLC, United States, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Medline

STRIPS,URINE,REAGENT,URO7,100 Strips/BT

Nitroprusside, Ketones (Urinary, Non-Quant.)

Fisherbrand

BHB Liquicolor RGT Beck

Nitroprusside, Ketones (Urinary, Non-Quant.)

Biocoach Blood Glucose and Ketone Monitoring System

Complete Kit

Nitroprusside, Ketones (Urinary, Non-Quant.)

Aimstrip US-K

Dipstick reagent strips for the qualitative detection of Ketone in Urine.

Nitroprusside, Ketones (Urinary, Non-Quant.)

STAT-Site Diluent

STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range…

Nitroprusside, Ketones (Urinary, Non-Quant.)

Fora

Blood Ketone Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Teco Diagnostics

Teco Diagnostics URS-2K-100GL Bottle With Label

Nitroprusside, Ketones (Urinary, Non-Quant.)

Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor®

For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Qtest K

100 strips/ 1 bottle

Nitroprusside, Ketones (Urinary, Non-Quant.)

LYZ

Catalogue number 100 strips 1 bottle, listed by Changchun LYZ Technology Co., Ltd., China, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

D-3 Hydroxybutyrate (Ranbut)

2 catalogue numbers from RB1007, listed by Randox Laboratories Limited, United Kingdom, under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Care Touch

Blood Ketone Monitoring system

Nitroprusside, Ketones (Urinary, Non-Quant.)

Β-Hydroxybutyrate 21 FS

For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Gojji Blood Ketone Test Strip

Gojji Blood Ketone Test Strip: 1 catalogue number listed by Gojji, Inc., under Nitroprusside, Ketones (Urinary, Non-Quant.). 17 manufacturers in China are registered for this product code.

Nitroprusside, Ketones (Urinary, Non-Quant.)

Bruno

Ketone Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Mission Urinalysis Reagent Strips

Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)

Nitroprusside, Ketones (Urinary, Non-Quant.)

TRUEplus

TRUEplus Ketone Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Cardinal Health

Beta-Hydroxybutyrate Liquicolor for Synchron CX/LX/DX

Nitroprusside, Ketones (Urinary, Non-Quant.)

Precision Xceed Pro

Precision Xceed Pro Blood Glucose Test Strips

Nitroprusside, Ketones (Urinary, Non-Quant.)

Ketostix®

Reagent Strips for Urinalysis: Ketone

Nitroprusside, Ketones (Urinary, Non-Quant.)

KetoSens

KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)

Nitroprusside, Ketones (Urinary, Non-Quant.)

Pointe Scientific, Inc.

Reagent for the quantitative determination of b-hydroxybutyrate in serum or plasma. For in vitro diagnostic use only. 1 x 50ml, 1 x 8ml

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