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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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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)
Product Description DSQ Alert® HT HAV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 23.4 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 90 bp region of the 5’ UTR of HAV. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, 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
M800815
In Commercial Distribution

  • 03661540952883 ()
M800815

  • Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)
1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgA ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708720
In Commercial Distribution

  • 08426950593805 ()


  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HORIBA ABX SAS
1220001980
In Commercial Distribution

  • 03610230005811 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
4489403190
In Commercial Distribution

  • 04015630920860 ()
4489403190

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-07
In Commercial Distribution

  • 10743816001485 ()
BSP-510AS-07

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
No Description
Roche Diagnostics GmbH
5219191190
In Commercial Distribution

  • 04015630925711 ()
5219191190

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Ovulation Preedictor
FOURSTAR GROUP INC.
11013002B
In Commercial Distribution

  • 00049696712682 ()


  • Varicella-zoster virus (VZV) immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 A
Not in Commercial Distribution

  • 04049016085492 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DN 2050-24001 A
Not in Commercial Distribution

  • 04049016085461 ()


  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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