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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® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
M800587-am
In Commercial Distribution

  • 03661540950087 ()
M800587-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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)
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
Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution

  • E241BW0900 ()

  • 1 pcs
BW090

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW035
In Commercial Distribution

  • E241BW0350 ()

  • 1 pcs
BW035

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW030
In Commercial Distribution

  • E241BW0300 ()

  • 1 pcs
BW030

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW015
In Commercial Distribution

  • E241BW0150 ()

  • 1 pcs
BW015

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW010
In Commercial Distribution

  • E241BW0100 ()

  • 1 pcs
BW010

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW000
In Commercial Distribution

  • E241BW0000 ()

  • 1 pcs
BW000

  • Dental bleaching agent
MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • Nucleic acid amplification primer IVD
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