Enzyme Immunoassay, Nicotine and Nicotine Metabolites

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Zhejiang: 2 hold an FDA registration. 2 are contract manufacturers.

Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

What Is FDA Product Code MKU?

Enzyme Immunoassay, Nicotine And Nicotine Metabolites is FDA product code MKU, Class 1, 21 CFR 862.3220.

What Does It Take to Sell It in the United States?

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.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Nano-CheckTM Nicotine

In Vitro Diagnostic Test kit for the detection of Cotinine in human urine

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Catalogue number 1124ET, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Rapid Response

Rapid Response Saliva Drug Test (COT)

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Status™ Nicotine Card

Status Nicotine™ card; 35 Test Kit

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Salimetrics

High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Cotinine OraSure 5 Plate Kit

Catalogue number 1124SB, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

LZI Cotinine II Enzyme Immunoassay

The LZI Cotinine II Enzyme Immunoassay detects cotinine in human urine as an aid in assessing use of or exposure to tobacco products. It is intended for prescription laboratory use with…

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

DRI Cotinine Calibrator Kit

Catalogue number 0404, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)

Catalogue number DCT-102a, listed by Alere San Diego, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Cotinine OraSure 100 Plate Kit

Catalogue number 1124SC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

DRI Cotinine High Control

Catalogue number 0470, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Auto-Lyte

Auto-Lyte Cotinine Urine 1000mL

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

AccuSign® Nicotine Card

AccuSign® Nicotine card; 35 Test Kit

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Cotinine Serum 5 Plate Kit

Catalogue number 1124EB, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

DRI Cotinine Assay

3 catalogue numbers from 0394, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Nano-CheckTM Nicotine 500

In Vitro Diagnostic Test kit for the detection of Cotinine in human urine

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Kit, MP Cotinine Serum 100 Plate

Catalogue number 1124EC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

DRI Cotinine Low Control

Catalogue number 0460, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Nicotine And Nicotine Metabolites. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Nicotine and Nicotine Metabolites

Which Manufacturers in China Make This?

What Is FDA Product Code MKU?

What Does It Take to Sell It in the United States?

Nano-CheckTM Nicotine

Cotinine Serum 2 Plate Kit

Rapid Response

Status™ Nicotine Card

Salimetrics

Cotinine OraSure 5 Plate Kit

LZI Cotinine II Enzyme Immunoassay

DRI Cotinine Calibrator Kit

SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)

Cotinine OraSure 100 Plate Kit

DRI Cotinine High Control

Auto-Lyte

AccuSign® Nicotine Card

Cotinine Serum 5 Plate Kit

DRI Cotinine Assay

Nano-CheckTM Nicotine 500

Kit, MP Cotinine Serum 100 Plate

DRI Cotinine Low Control

Where China Actually Supplies