Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015; N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015; N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016; N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.
Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
Description du dispositif
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. || A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
Alere INRatio PT/INR Test Strips, Alere INRatio || PT/INR System Professional || - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 || - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 || The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. || In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
INRatio Monitors || - 0100004 Alere INRatio PT/INR System Professional || - 0100007 INRatio Prothrombin Time (PT) Monitoring System || - 0100137 Alere INRatio Replacement Monitor || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Description du dispositif
INRatio 2 Monitors || - 0200431 Alere INRatio 2 PT/INR Professional Testing System || - 0200432 Alere INRatio 2 PT/INR Home Monitoring System || - 0200433 Alere INRatio 2 PT/INR Home Monitoring System || - 0200457 Alere INRatio 2 Replacement Monitor || - 55112 Alere INRatio 2 Replacement Monitor || - 55131 Alere INRatio 2 Replacement Monitor || - 55128A Alere INRatio 2 PT/INR Professional Monitoring System || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
Description du dispositif
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; || Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies || : || Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone . MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
Description du dispositif
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and || 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) || The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The || PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react || with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic || compounds. The PF4 IgG kit contains all of the reagents necessary to perform || the assay.