Devices

MONOLISA

  • Model / Serial
    Lot 131BHH, Catalog # 26174
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
  • Product Description
    Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
  • Manufacturer
    Bio-Rad Laboratories
  • 1 Event

Manufacturer

Bio-Rad Laboratories
  • Manufacturer Address
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA

17 devices with a similar name

Learn more about the data here

monolisa ™ HCV Ag-Ab ultra V2
MONOLISA HCV Ag-Ab ULTRA kits
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIORAD
MONOLISA® anti-HCV Plus version 2
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIO-RAD
Monolisa HCV
  • Model / Serial
    Code numbers: 72561, 72562 Multple Lot numbers of the affected device are provided in the attached FSN.
  • Product Description
    Reagents, Serology, Virus
  • Manufacturer
    Bio Rad
Monolisa™ HCV Ag-Ab ULTRA V2 Assay
  • Model / Serial
    Catalog Number: 72561 (1 destička - 96 testů) a 72562 (5 destiček - 480 testů) Batch Number: 6J0029, 6K0030, 6K0031, 6M0032, 7A0033 a 6J0533, 6K0534, 6K0535, 6M0536
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Bio-Rad Laboratories
12 more