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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® JC Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from JC Virus. The mix consists of a total of 6.48 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 78 bp nucleic acid sequence from the VP2 Tantigen region of JC Virus"
Elitechgroup Mdx LLC
M800601
In Commercial Distribution

  • 03661540950346 ()
M800601

  • JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert Internal Control Set IC2-8 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 IC2-8 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
M800600
In Commercial Distribution

  • 03661540950322 ()
M800600

  • Exogenous DNA/RNA internal control IVD, kit
"MGB Alert® HHV8 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ORF26 gene region in HHV8. The mix consists of one probe at 0.72 nmol 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
M800598
In Commercial Distribution

  • 03661540950308 ()
M800598

  • Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV8 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HHV8. The mix consists of a total of 8.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 109 bp nucleic acid sequence from the ORF26 gene region in HHV8."
Elitechgroup Mdx LLC
M800597
In Commercial Distribution

  • 03661540950285 ()
M800597

  • Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
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
M800599
In Commercial Distribution

  • 03661540950278 ()
M800599

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Internal Control Set IC2-T 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-T 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
M800580-am
In Commercial Distribution

  • 03661540950254 ()
M800580-am

  • Exogenous DNA/RNA internal control IVD, kit
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
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
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
No Description
DIASORIN MOLECULAR LLC
MOL9202
In Commercial Distribution

  • 10816101027283 ()
MOL9202

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9771
In Commercial Distribution

  • 10816101027207 ()
MOL9771

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9207
In Commercial Distribution

  • 10816101027313 ()
MOL9207

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9203
In Commercial Distribution

  • 10816101027306 ()
MOL9203

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9178
In Commercial Distribution

  • 10816101027290 ()
MOL9178

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9773
In Commercial Distribution

  • 10816101027221 ()
MOL9773

  • Assay development analyte-specific reagent IVD
CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
MEDTRONIC, INC.
550-10
In Commercial Distribution

  • 10885074184927 ()
  • 00885074184920 ()


  • Multiple coagulation factor IVD, control
CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-09
In Commercial Distribution

  • 10885074184910 ()
  • 00885074184913 ()


  • Multiple coagulation factor IVD, control
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