FDA-Device2022-09-07Class II
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
bioMerieux, Inc.
Hazard
There are 7 reported software anomalies that may affect use of the device.
Sold states
International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2022Don't want to check this manually?
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