Antigens, Ha (Including Ha Control), Adenovirus 1-33

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Hunan and Jiangsu: 2 hold an FDA registration.

AVE Science & Technology Co., Ltd. Hunan
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. Jiangsu

How Is GOB Classified?

Antigens, Ha (Including Ha Control), Adenovirus 1-33 is FDA product code GOB, Class 1, 21 CFR 866.3020.

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.

Antigens, Ha (Including Ha Control), Adenovirus 1-33

Detection Kit for Group a Rotavirus and Adenovirus Antigens (Colloidal Gold)

2 catalogue numbers from 50 tests/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Antigens, Ha (Including Ha Control), Adenovirus 1-33. 2 manufacturers in China are registered for this product code.

Antigens, Ha (Including Ha Control), Adenovirus 1-33

Adenovirus Antigen Detection Kit (Immunochromatography)

2 catalogue numbers from 1 test/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Antigens, Ha (Including Ha Control), Adenovirus 1-33. 2 manufacturers in China are registered for this product code.

Antigens, Ha (Including Ha Control), Adenovirus 1-33

Which Manufacturers in China Make This?

How Is GOB Classified?

How Does It Reach the US Market?

Detection Kit for Group a Rotavirus and Adenovirus Antigens (Colloidal Gold)

Adenovirus Antigen Detection Kit (Immunochromatography)

Where China Actually Supplies