Devices

Device Recall PAX8 (MRQ50 Mab) CM

Model / Serial
Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019
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, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
Manufacturer
Leica Biosystems Richmond Inc.
1 Event
- Recall of Device Recall PAX8 (MRQ50 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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