Devices

Device Recall Glypican3 (1G12 Mab) CM

Model / Serial
Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Product Description
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
Manufacturer
Leica Biosystems Richmond Inc.
1 Event
- Recall of Device Recall Glypican3 (1G12 Mab) CM

Manufacturer

Leica Biosystems Richmond Inc.

Manufacturer Address
Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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