Kit, Serological, Negative Control

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Guangdong.

Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. Guangdong

What Is FDA Product Code MJY?

Kit, Serological, Negative Control is FDA product code MJY, Class 1, 21 CFR 862.1660.

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.

Kit, Serological, Negative Control

Architect

ARCHITECT HAVAB-G Reagent Kit

Kit, Serological, Negative Control

Serology Lyme Disease Negative Control (Lyme Control -)

Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM…

Kit, Serological, Negative Control

Access HIV Ag/Ab Combo QC

The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay…

Kit, Serological, Negative Control

Which Manufacturers in China Make This?

What Is FDA Product Code MJY?

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

Architect

Serology Lyme Disease Negative Control (Lyme Control -)

Access HIV Ag/Ab Combo QC

Where China Actually Supplies