FDA-Device2018-07-25Class II
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.
Opgen Inc
Hazard
Possible diminished performance prior to its established expiration date.
Sold states
Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
Affected count
800 total (32 kits/25 slides per kit)
Manufactured in
708 Quince Orchard Rd Ste 220, Gaithersburg, MD, United States
Products
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2018Don't want to check this manually?
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