Instrumentation Laboratory Co.

38 devices in the database

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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).
  • Model / Serial
    Lot Numbers:  B01424 Exp Date: March 31 , 2012; B11498 Exp Date: July, 31 , 2012; B11655 Exp Date: November 30, 2012; B11687 Exp Date: January 31 , 2013
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS BELGIUM, BRAZIL, CHILE, CHINA, CZECH REPUBLIC, DENMARK FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF KUWAIT LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, and the UNITED ARAB EMIRATES
  • Product Description
    Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit || Part Number: 0020004700 || The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
  • Model / Serial
    Serial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
  • Product Description
    Instrumentation Laboratory ACL TOP 700 CTS || PN 0000280050 || ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
  • Model / Serial
    Serial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
  • Product Description
    Instrumentation Laboratory ACL TOP (Base) || PN 0000280000 || ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
  • Model / Serial
    Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
  • Product Description
    Instrumentation Laboratory ACL TOP 700 || PN 0000280010 || ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
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16 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Instrumentation Laboratory Co., 180 Hartwell Rd, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Avenue, Lexington MA 02173
  • Source
    USFDA
  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
  • Source
    USFDA
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