25 results
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30ms
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Sources: EU EUDAMED, US FDA
ENTERIX INC.
FDA registration
ENTERIX INC.·2 products·🇺🇸 United States
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003279·InSure® ONE™ Combo Pack - contains 25 Collectio...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003040·InSure FIT Combo Pack
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003286·InSure® ONE™ Test Cards for QC - 50 pack
InSure FIT
FDA UDI
ENTERIX INC.·00850093003187·InSure FIT Sample Kit - NOT FOR SALE
Contains 2...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003071·InSure FIT Test Cards for QC - 50 pack
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003293·InSure® ONE™ Run Buffer - 1 Liter Bottle
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003231·InSure® ONE™ Developer Kit - contains 25 indivi...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003033·InSure FIT FOBT Controls
- Contains 1 Positiv...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003064·InSure FIT Kit
InSure FIT
FDA UDI
ENTERIX INC.·00850093003019·InSure FIT Developer Kit
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003354·InSure® ONE™ Combo Pack - contains 35 Collectio...
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003323·InSure® ONE™ Test Strip: Sold in Vials of 25 St...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003088·InSure FIT Test Strip
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003309·InSure® ONE™ Sample Kit - NOT FOR SALE
Contains...
InSure FIT
FDA UDI
ENTERIX INC.·00850093003095·InSure FIT Run Buffer - 1 Liter Bottle
InSure® ONE™
FDA UDI
ENTERIX INC.·00850093003316·InSure® ONE™ Collection Kit: Available in 10-pa...
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 Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
FDA Recall
Open, Classified
·Enterix, Inc.·Product code KHE·September 17, 2025