Devices

Device Recall EVOLIS Assay Protocol Files ( APF) Software

Model / Serial
APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- Including Puerto Rico.
Product Description
Software CD is labeled in part: || "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" || The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
Manufacturer
Bio-Rad Laboratories
1 Event
- Recall of Device Recall EVOLIS Assay Protocol Files ( APF) Software

Manufacturer

Bio-Rad Laboratories

Manufacturer Address
Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
Manufacturer Parent Company (2017)
Bio-Rad Laboratories Inc
Source
USFDA

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