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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BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
BECTON, DICKINSON AND COMPANY
442970
Not in Commercial Distribution

  • 00382904429706 ()
442970

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 10812125010058 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800331
In Commercial Distribution

  • 03661540951787 ()
M800331

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800547
In Commercial Distribution

  • 03661540951725 ()
M800547

  • Nucleic acid amplification mastermix kit IVD
3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007313 ()


  • Orthopaedic cement dispenser
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Spanish, Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 SB
In Commercial Distribution

  • D801SP65023SB1 ()
65-023

  • Dentine adhesive
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952784 ()


  • Nucleic acid amplification primer IVD
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
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952326 ()


  • Nucleic acid amplification primer IVD
VPS Impression Material
DEN-MAT HOLDINGS, LLC
013386
In Commercial Distribution

  • 00359883006006 ()

  • Total Volume: 380 Milliliter
013386

  • Silicone dental impression material
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