Devices

Device Recall Microphthalmia Transcription Factor

Model / Serial
Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019
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, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
Manufacturer
Leica Biosystems Richmond Inc.
1 Event
- Recall of Device Recall Microphthalmia Transcription Factor

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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