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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Clement Clarke Ophthalmic - 05060179470146

SYNOPTOPHORE MODEL 2003 (11)
HAAG-STREIT UK LIMITED
6403001ULUS
In Commercial Distribution

  • 05060179470146 ()
6403001ULUS

  • Synoptophore

Clement Clarke Ophthalmic - 05060179470030

SYNOPTOPHORE MODEL 2002 (11)
HAAG-STREIT UK LIMITED
6402001ULUS
In Commercial Distribution

  • 05060179470030 ()
6402001ULUS

  • Synoptophore

Clement Clarke Ophthalmic - 05060179470023

SYNOPTOPHORE MODEL 2001 (11)
HAAG-STREIT UK LIMITED
6401001ULUS
In Commercial Distribution

  • 05060179470023 ()
6401001ULUS

  • Synoptophore

Optimal Hypotonic Solution - 05060174130106

Optimal Hypotonic Solution is a hypotonic solution which achieves optimum metaphase swelling (spreading) from difficult cells prone to either under spread or overspread where conventional hypotonic solutions achieve inadequate swelling. The solution increases cell volume allowing the chromosomes more room to spread; well spread chromosomes with few crossovers greatly aid analysis. Developed for acute leukaemia bone marrow and tumour cells, also useful with problem blood and other problematic sample types.
GENIAL HELIX LTD
GGS - JL005
In Commercial Distribution

  • 05060174130106 ()
GGS - JL005

  • Assay development analyte-specific reagent IVD

Buffered Hypotonic Solution - 05060174130090

Buffered Hypotonic Solution is a hypotonic solution developed for bone marrow specimens. It has been found to achieve good metaphase swelling (spreading) from a wide range of sample types and significantly increases the number of useful metaphases in leukaemic bone marrow cultures.
GENIAL HELIX LTD
GGS - JL006
In Commercial Distribution

  • 05060174130090 ()
GGS - JL006

  • Assay development analyte-specific reagent IVD

Pre-Hypotonic Solution - 05060174130083

Pre-Hypotonic Solution is to be used before the hypotonic stage of a blood or bone marrow harvest; pre-hypotonic solution makes the hypotonic step more effective by circumventing the tendency of chromosomes to clump or to under-spread.
GENIAL HELIX LTD
GGS - JL007
In Commercial Distribution

  • 05060174130083 ()
GGS - JL007

  • Assay development analyte-specific reagent IVD

Metaphase Arresting Solution - 05060174130076

Metaphase Arresting Solution is a mixture of colchicine/vinblastine sulphate dissolved in PBS. Both of these compounds inhibit the formation of mitotic spindles and are used to increase the percentage of metaphase cells for chromosome studies. Vinblastine sulphate has been found to be more effective against bone marrows, difficult tumours and problematic tissues with low mitotic indexes, and where colchicine/colcemid appears to be ineffective.
GENIAL HELIX LTD
GGS - JL008
In Commercial Distribution

  • 05060174130076 ()
GGS - JL008

  • Assay development analyte-specific reagent IVD

Chromosome Resolution Additive - 05060174130069

Chromosome Resolution Additive is a formulation that consistently prevents chromosome contraction and encourages chromosome elongation by loosening the chemical bonding within the supercoiled structure. It has been designed for use with tissues resistant to existing prophase techniques such as bone marrows and solid tumors.
GENIAL HELIX LTD
GGS - JL003
In Commercial Distribution

  • 05060174130069 ()
GGS - JL003

  • Assay development analyte-specific reagent IVD

Bone Marrow Growth Supplement - 05060174130052

Is a media additive that greatly improves cell growth and cytogenetic morphology in bone marrow cultures by exposing these cells to growth factors that are known growth promoters. The additive is also effective with difficult-to-grow solid tumours, lymphomas and products of conception.
GENIAL HELIX LTD
GGS - JL002
In Commercial Distribution

  • 05060174130052 ()
GGS - JL002

  • Assay development analyte-specific reagent IVD

Erythrocyte Lysis Solution - 05060174130038

Erythrocyte Lysis Solution is a simple pretreatment for heavily blood-stained amniotic fluid and bone marrow samples which quickly removes heavy red blood cell (erythrocyte) contamination. Unlike many similar products used in molecular biology that lyse red blood cells, this product is extremely gentle in its action and is specially suited for cytogenetic cell culture work. It is well documented that high concentrations of red blood cells inhibit growth of cells from amniotic fluid by restricting colony size.
GENIAL HELIX LTD
GGS - JL009
In Commercial Distribution

  • 05060174130038 ()
GGS - JL009

  • Assay development analyte-specific reagent IVD
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