Devices

Device Recall Stago IVD, Liquid AntiXa

Model / Serial
510(k) #K111822, Lot #112366, Part # REF 00311US
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed USA (nationwide) and the country of Canada.
Product Description
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. || The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Manufacturer
Diagnostica Stago, Inc.
1 Event
- Recall of Device Recall Stago IVD, Liquid AntiXa

Manufacturer

Diagnostica Stago, Inc.

Manufacturer Address
Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
Source
USFDA

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