Boston Biomedica, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 11
Catalogue
Accurun 140 Rubella Igg Positive Control Ref K972986
Accurun 121 Hav Igm Positive Control Ref K971657
Accurun 135 Toxoplasma Igg Positive Control Ref K974261
Accurun(Tm) 150 Hsv Igg Positive Control Ref K974811
Accurun 117 Hbeag Positive Control Ref K972048
Accurun 120 Hav Igg Positive Control Ref K971406
Accurun 146 Cmv Igm Positive Control Ref K972884
What Boston Biomedica, Inc. makes
Boston Biomedica, Inc. manufactures diagnostic controls and immunoassay kits for infectious disease testing, including positive controls for hepatitis A virus (HAV), toxoplasma, herpes simplex virus (HSV), cytomegalovirus (CMV), and Borrelia burgdorferi (Lyme disease). Their portfolio also includes Western blot kits for detecting Borrelia burgdorferi IgM and IgG antibodies, as well as IgM/IgG detection assays for the same pathogen.
The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). Their diagnostic controls and immunoassay kits are listed in the FDA’s 510(k) database and are intended for use in clinical and research laboratories in the United States.
Frequently asked questions
How many devices does Boston Biomedica, Inc. have in the registry?
The registry currently lists 11 devices for Boston Biomedica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Biomedica, Inc.'s devices?
Among its 11 most recently registered devices, Boston Biomedica, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Boston Biomedica, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Boston Biomedica, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boston Biomedica, Inc. in the registry?
The most recently registered devices listed for Boston Biomedica, Inc. include ACCURUN 140 RUBELLA IGG POSITIVE CONTROL, ACCURUN 121 HAV IGM POSITIVE CONTROL, ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL and BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT.