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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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For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis
ELITECHGROUP INC.
SS-268-ND
In Commercial Distribution

  • 03661540304385 ()


  • Sweat-induction iontophoresis system
For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-268
In Commercial Distribution

  • 03661540304378 ()


  • Sweat-induction iontophoresis system
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
The MGB Alert Internal Control MS2 RNA Template consists of an RNA bacteriophage intended for use as an internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800740
In Commercial Distribution

  • 03661540952425 ()


  • Nucleic acid amplification primer IVD
MS2 RNA Internal Control in TE-Yeast RNA
Elitechgroup Mdx LLC
M800698
In Commercial Distribution

  • 03661540951992 ()
M800698

  • Endogenous DNA/RNA internal control IVD, reagent
"MGB Alert® HHV-6 2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from the U67 gene of Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "
Elitechgroup Mdx LLC
800500
In Commercial Distribution

  • 03661540951985 ()
800500

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® B. pertussis / B. parapertussis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Bordetella pertussis and Bordetella parapertussis. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis."
Elitechgroup Mdx LLC
800437
In Commercial Distribution

  • 03661540951961 ()
800437

  • Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis. 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
800438
In Commercial Distribution

  • 03661540951886 ()
800438

  • Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set IC1-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes
Elitechgroup Mdx LLC
800361
In Commercial Distribution

  • 03661540951862 ()
800361

  • Exogenous DNA/RNA internal control IVD, kit
"The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data."
Elitechgroup Mdx LLC
M800694
In Commercial Distribution

  • 03661540951824 ()
M800694

  • Nucleic acid amplification mastermix kit IVD
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