Devices

Device Recall MicroVue SC5b9 Plus EIA (RUO)

Model / Serial
Lot 052418
Product Classification
Immunology and Microbiology Devices
Device Class
Not Classified
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Product Description
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Manufacturer
Diagnostic Hybrids, Inc.
1 Event
- Recall of Device Recall MicroVue SC5b9 Plus EIA (RUO)

Manufacturer

Diagnostic Hybrids, Inc.

Manufacturer Address
Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
Manufacturer Parent Company (2017)
Quidel Corporation
Source
USFDA

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