Paragon

in-vitro_medical_device

Model 12.1 and 12.1.1

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution including Puerto Rico and to the states of : CA, CO., CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OA, PA, SC, SD, TN, TX, VT, VA, WV and WY.

Paragon Laboratory Management

Lot numbers: 262111 (manufactured June 2002, expires May 2005) 282233 (manufactured August 2002, expires July 2005)

General Hospital and Personal Use Devices

2

No

States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.

Paragon Administration Set (100 ml x 0.5 ml/hr) || Part Number 5000936

M308363 (250 test) M309039 (50 test)  10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.

Immunology and Microbiology Devices

2

No

IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. || Part Numbers: || 446360 (250 test kit) || 446260 (50 test kit) || 444970 (10 test kit)

Surgical equipment/ Anaesthesia - surgical equipment