GenBio is ISO 13485 and FDA compliant meeting the standards required as a human device manufacturer. The Registrations and Licenses link includes U.S. and California FDA, ISO, CE mark and NCCLS information. We provide an extensive technical report listing. These reports provide answers for you or your customers. We also list publications related to our products. We separate these publications into two categories, those publications listed in the package insert and newer publications either about our product or related to the product.

If you don't see what you're looking for, please contact us for more information.

GenBio has prepared Microsoft Excel spreadsheets to assist you. Please find below those spread sheets for your use.

Infectious Diseases	Run Sheet
Borrelia Lyme
ImmunoWELL Borrelia (IgG,IgA,IgM) 96 test kit, 1 point calibration	700-0128
Epstein-Barr Virus (EBV)
ImmunoWELL EBV EA (D) IgG 96 test kit, 3 point calibration	700-0125
ImmunoWELL EBV EA (D) IgG 96 test kit, 1 point calibration	700-0144
ImmunoWELL EBV VCA IgG 96 test kit, 3 point calibration	700-0120
ImmunoWELL EBV VCA IgG 96 test kit, 1 point calibration	700-0121
ImmunoWELL EBV VCA IgM 96 test kit, 3 point calibration	700-0122
ImmunoWELL EBV VCA IgM 96 test kit, 1 point calibration	700-0123
ImmunoWELL EBV EBNA IgG 96 test kit, 3 point calibration	700-0118
ImmunoWELL EBV EBNA IgG 96 test kit, 1 point calibration	700-0119
ImmunoWELL EBV EBNA (800) IgG 96 test kit, 3 point calibration	700-0137
ImmunoWELL EBV EBNA (800) IgG 96 test kit, 1 point calibration	700-0136
ImmunoWELL EBV EBNA (1000) IgG 96 test kit, 3 point calibration	700-0139
ImmunoWELL EBV EBNA (1000) IgG 96 test kit, 1 point calibration	700-0138
Herpes Simplex Virus (HSV)
ImmunoWELL HSV Type 1 IgG . 96 test kit (CE only), 3 point calibration	700-0153
ImmunoWELL HSV Type 1 IgG . 96 test kit (CE only), 1 point calibration	700-0152
ImmunoWELL HSV Type 2 IgG . 96 test kit (CE only), 3 point calibration	700-0155
ImmunoWELL HSV Type 2 IgG . 96 test kit (CE only), 1 point calibration	700-0154
Measles Virus (Rubeola)
ImmunoWELL Measles Virus IgG . 96 test kit (CE only), 3 point calibration	700-0544
ImmunoWELL Measles Virus IgG . 96 test kit (CE only), 1 point calibration	700-0543
ImmunoWELL Measles Virus IgM . 96 test kit (CE only), 1 point calibration	700-0545
Mumps Virus
ImmunoWELL Mumps Virus IgG . 96 test kit (CE only), 3 point calibration	700-0549
ImmunoWELL Mumps Virus IgG . 96 test kit (CE only), 1 point calibration	700-0548
Mycoplasma Pneumoniae
ImmunoWELL M. pneumoniae IgG . 96 test kit, 1 point calibration	700-0126
ImmunoWELL M. pneumoniae IgM . 96 test kit, 1 point calibration	700-0127
Varicella Zoster Virus (VZV)
ImmunoWELL Varicella Zoster Virus IgG . 96 test kit (CE only), 3 point calibration	700-0547
Autoimmune Diseases
ImmunoWELL Cardiolipin Antibodies IgG . 96 test kit, 3 point calibration	700-0142
ImmunoWELL Cardiolipin Antibodies IgM . 96 test kit, 3 point calibration	700-0143
ImmunoWELL Thyroglobulin Antibodies IgG . 96 test kit, 5 point calibration	700-0129
ImmunoWELL TPO Antibodies IgG . 96 test kit, 5 point calibration	700-0130
ImmunoWELL dsDNA Antibodies IgG . 96 test kit, 3 point calibration	700-0131