Mainline Technology, Inc.

Lot 25310 and 25831.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- United States, Belgium and Switzerland.

Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. || The product is used as a pregnancy test.

Lot No: 94300.

Immunology and Microbiology Devices

1

No

Nationwide Distribution.

Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).

Lots 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.

Lot 20087.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.

Lots 96101- 96206, 96218, 96235, 96260, 96295, 96300, 96320, 96360, 96380, and 96381.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25.