Devices

InSure(R) Quik FIT(TM)

Model / Serial
Lot number B1478, Exp. Date 11/30/2008
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to medical facilities and laboratories throughout the US.
Product Description
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.
Manufacturer
Enterix, Inc.
1 Event
- Recall of InSure(R) Quik FIT(TM)

Manufacturer

Enterix, Inc.

Manufacturer Address
Enterix, Inc., 236 Fernwood Ave, Edison NJ 08837-3839
Manufacturer Parent Company (2017)
Enterix Inc.
Source
USFDA

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