Abbott Molecular

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Description

16 devices in the database

  • Model / Serial
    list 07J02-002, part number 32-801210, lot numbers 420563, 420008 and 418294
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
  • Product Description
    Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.
  • Model / Serial
    list 07J02-003, part number 32-801230, lot numbers 420063 and 418669
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
  • Product Description
    Paraffin Pretreatment Reagent Kit III; each kit contains the following: || 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), || 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), || 5 x 9.0 mg Protease III (Proteinase K, 35 <= x <= 38 Units/mg) || 2 x 200 mL Protease Stop Solution (0.01N hydrochloric acid - HCl); || Abbott Molecular Inc; list 07J02-003, part number 32-801230. invitro diagnostic.
  • Model / Serial
    All basins distributed since September 2008.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.
  • Product Description
    VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: || a) list 02J11-013, part number 30-144152 (replacement basins); || b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); || c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); || d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); || Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
  • Model / Serial
    All in date lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA || The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.
  • Model / Serial
    All in date lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA || The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.
11 more

14 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP
9 more