Point

Model Catalog: 0678-001-000 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 0678-001-000 (Lot serial: >125 LOT/SERIAL NUMBERS)

SWITCHPOINT INFINITY 3

Model Catalog: 130521 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 130520 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10283221 (Lot serial: MORE THAN 10 SERIAL NUMBERS.)

RAPIDPOINT 405 SYSTEM CARTRIDGES

Serial Numbers: 1001, 1002, and 1003

Radiology Devices

2

No

Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.

Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

All software versions

Radiology Devices

2

No

Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.

CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361.)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.

Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. || For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.