Tosoh Bioscience Inc

All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - U.S. Nationwide - Latin America

Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. || Product Usage: || The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - U.S. Nationwide - Latin America

Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. || Product Usage: || The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240

All Lot Codes

Immunology and Microbiology Devices

2

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK 27.29; Part Number: 025202 || Assay, Tumor Marker