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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VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013386
In Commercial Distribution

  • 07540172017046 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013385

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013381
In Commercial Distribution

  • 07540172017039 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013380

  • Silicone dental impression material
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)
Product Description DSQ Alert® HT Norovirus GII Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. The mix consists of a total of 41.6 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 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. 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
M800821
In Commercial Distribution

  • 03661540952869 ()
M800821

  • Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description DSQ Alert® HT Norovirus GI Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. The mix consists of a total of 41.6 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 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. 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. Warnings and Precautions Carefully read
Elitechgroup Mdx LLC
M800819
In Commercial Distribution

  • 03661540952845 ()
M800819

  • Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 3.9 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
M800814
In Commercial Distribution

  • 03661540952838 ()
M800814

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 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 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method. 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
M800813
In Commercial Distribution

  • 03661540952821 ()
M800813

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm.
Elitechgroup Mdx LLC
M800759
In Commercial Distribution

  • 03661540952708 ()
M800759

  • Human parechovirus (HPeV) nucleic acid IVD, reagent
DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 130 bp region of the 5’-UTR of parechovirus.
Elitechgroup Mdx LLC
M800758
In Commercial Distribution

  • 03661540952692 ()
M800758

  • Human parechovirus (HPeV) nucleic acid IVD, reagent
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