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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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Cyclosporine Extended Range Flex® reagent cartridge, 60 Tests
Siemens Healthcare Diagnostics Inc.
10445142
Not in Commercial Distribution

  • 00842768016035 ()
  • 00630414005096 ()
K4108

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Cyclosporine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445139
Not in Commercial Distribution

  • 00842768015144 ()
  • 00630414005089 ()
K4089

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
7507US
In Commercial Distribution

  • 04250289503143 ()
7507US

  • Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7507US
In Commercial Distribution

  • 04250289502894 ()
30-7507US

  • Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
3507
In Commercial Distribution

  • 04250289501521 ()


  • Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
Quantia ASO
ABBOTT LABORATORIES
6K38-50
In Commercial Distribution

  • 00380740057701 ()
06K3850

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
ARCHITECT HAVAB-G Reagent Kit
Abbott GmbH
6L27-25
In Commercial Distribution

  • 00380740011185 ()
06L2725

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Quantia ASO
ABBOTT LABORATORIES
06K3851
In Commercial Distribution

  • 00380740156251 ()
06K3851

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Alinity c ASO Reagent Kit 300 Tests
ABBOTT LABORATORIES
01R0621
In Commercial Distribution

  • 00380740153564 ()
01R0621

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Product Description DSQ Alert® HT HAV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800816
In Commercial Distribution

  • 03661540952890 ()
M800816

  • Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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