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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No Description
Lonza Verviers
BESP808B0.5
In Commercial Distribution

  • 05407010121568 ()
BESP808B0.5

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X10
Not in Commercial Distribution

  • 05407010124507 ()
BESP808X10

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP698P20S
In Commercial Distribution

  • 05407010126983 ()
BESP698P20S

  • Ex vivo cell culture medium
"MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800421
In Commercial Distribution

  • 03661540951534 ()
800421

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus. 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
M800726
In Commercial Distribution

  • 03661540952746 ()


  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ Candida auris Probe Mix ASR is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 of Candida auris.
Elitechgroup Mdx LLC
800730
In Commercial Distribution

  • 03661540952548 ()
800730

  • Assay development analyte-specific reagent IVD
DSQ Alert™ Candida auris Primer Mix ASR is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify an 125 bp region within the ITS2 gene of Candida auris. The mix consists of a single vial containing a set of primers in a 1X TE buffer solution.
Elitechgroup Mdx LLC
800729
In Commercial Distribution

  • 03661540952531 ()
800729

  • Assay development analyte-specific reagent IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800810
In Commercial Distribution

  • 03661540952524 ()
M800810

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800809
In Commercial Distribution

  • 03661540952517 ()
M800809

  • Nucleic acid amplification mastermix kit IVD
MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800498
In Commercial Distribution

  • 03661540951671 ()
800498

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
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