Qualigen Inc

Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

FastPack Free T4 Immunoassay || FastPack Vitamin D Immunoassay || Chemilunescence assay for the determination of Vitamin D || The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.

Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

FastPack Free T4 Immunoassay || Chemilunescence assay for the determination of Free T4 || The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.

Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

FastPack Testosterone Immunoassay || Chemilunescence assay for the determination of Testosterone || The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.

Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

Immunology and Microbiology Devices

2

No

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

FastPack Total PSA Immunoassay || Chemilunescence assay for the determination of Total PSA. || FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.

Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.

Immunology and Microbiology Devices

2

No

Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.

FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 || Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.