3 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.
FDA Recall
Terminated
·Enterix, Inc.·Product code KHE·October 3, 2008
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
FDA Recall
Terminated
·Enterix, Inc.·Product code KHE·October 8, 2020
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
FDA Enforcement
Class II
·Terminated·Enterix, Inc.·December 23, 2020