Test, Phencyclidine (Pcp), Over the Counter
Which Manufacturers in China Make This?
12 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Guangdong and Anhui. 3 of them are contract manufacturers, able to build to a buyer’s own specification.
- Anhui Deepblue Medical Technology Co., Ltd. Anhui, contract manufacturer
- Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Co-Innovation Biotech Co., Ltd. Guangdong, contract manufacturer
- Eterbio, Inc. Guangdong
- Guangzhou Decheng Biotechnology Co., Ltd. Guangdong
- Hangzhou Aichek Medical Technology Co., Ltd. Zhejiang
- Hangzhou Clongene Biotech Co., Ltd. Zhejiang
- Hangzhou AllTest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Safecare Biotech(Hangzhou)Co., Ltd. Zhejiang
- Vivachek Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is It?
The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine.
What Is FDA Product Code NGM?
Test, Phencyclidine (Pcp), Over The Counter is FDA product code NGM, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.