Medtest Holdings, Inc.

Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

Pointe Scientific Hitachi Total Bilirubin Rl Reagent || Product Usage: || Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.

L7572 all configurations

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set || Model Number(s): L7572. || For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide

Pointe Scientific Chemistry Controls Level I and II || LEVl: Amber glass vial w/PP white plastic cap. || LEV2: Amber glass vial w/PP black plastic cap.

Model #'s C7568-CTL and C7568-STD  Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE

Pointe Scientific CRP(HS) Wide Range Control Set and || Pointe Scientific CRP(HS) Wide Range Standard Set || 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only