FDA product code SGW: Device To Detect Antibodies To Hepatitis D Virus

SGW is the FDA product code for device to detect antibodies to hepatitis d virus. It is a Class II device, regulated under 21 CFR 866.3176 and reviewed by the Microbiology panel. Devices under SGW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors.

Classification

Recalls for SGW devices

openFDA lists no recalls for product code SGW.

Frequently asked questions

What is FDA product code SGW?

SGW is the FDA product code for device to detect antibodies to hepatitis d virus. It is a Class II device, regulated under 21 CFR 866.3176 and reviewed by the Microbiology panel.

What device class is SGW?

Class II, regulation 21 CFR 866.3176. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SGW
• Run a recall and safety report across every SGW manufacturer
• Watch product code SGW for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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