Bio-Rad Laboratories

Lot 131BHH, Catalog # 26174

Immunology and Microbiology Devices

3

No

Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.

Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.

Lot #46704.

Immunology and Microbiology Devices

1

No

Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.

BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. || Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". || BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.

Catalog #: 663-1430 Lot #: 46636

Immunology and Microbiology Devices

2

No

Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.

BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 || The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.

APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2

Immunology and Microbiology Devices

2

No

Nationwide Distribution -- Including Puerto Rico.

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.

MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.

Immunology and Microbiology Devices

2

No

Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.

"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" || The test kit contains slides and substrate. || For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.