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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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MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Elitechgroup Mdx LLC
M800573
In Commercial Distribution

  • 03661540950056 ()
M800573

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800572
In Commercial Distribution

  • 03661540950049 ()
M800572

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set IC2-BH 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 IC2-BH 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
M800574
In Commercial Distribution

  • 03661540950032 ()
M800574

  • Exogenous DNA/RNA internal control IVD, kit
For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-032-ND
In Commercial Distribution

  • 03661540302169 ()


  • Sweat-induction iontophoresis system
For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-032
In Commercial Distribution

  • 03661540302152 ()


  • Sweat-induction iontophoresis system
For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-023
In Commercial Distribution

  • 03661540302084 ()


  • Sweat-induction iontophoresis system
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
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
Not in Commercial Distribution

  • 08600105181752 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
Refrigeration Test Yolk Buffer with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90129-20x5mL
In Commercial Distribution

  • 00893727002866 ()
  • 10893727002863 ()

  • Total Volume: 5 Milliliter
90129

  • IVF medium
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