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 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 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-am
In Commercial Distribution

  • 03661540950193 ()
M800331-am

  • Nucleic acid amplification mastermix kit IVD
No Description
DETAX GmbH
03913
In Commercial Distribution

  • EDET039131 ()


  • Earmould impression material
No Description
Lonza Walkersville, Inc.
15-1007XS
In Commercial Distribution

  • 00840075404071 ()
15-1007XS

  • Cell culture medium IVD
No Description
Lonza Walkersville, Inc.
15-1007I
In Commercial Distribution

  • 00840075403180 ()
15-1007I

  • Ex vivo cell culture medium
No Description
PEARSON DENTAL SUPPLIES, INC.
D440752
In Commercial Distribution

  • D724D4407521 ()


  • Orthodontic bracket adhesive
600ml
PEARSON DENTAL SUPPLIES, INC.
D010426
In Commercial Distribution

  • D724D0104260 ()


  • Polysulfide dental impression material
600ml
PEARSON DENTAL SUPPLIES, INC.
D010400
In Commercial Distribution

  • D724D0104000 ()


  • Polysulfide dental impression material
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
RELIANCE ORTHODONTIC PRODUCTS INC
DCCCCK
Not in Commercial Distribution

  • D798DCCCCK0 ()
DCCCCK

  • Dentine bonding agent/set
  • Orthodontic aligner auxiliary attachment kit
  • Orthodontic bracket adhesive
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007320 ()


  • Synthetic bone graft
  • Bone matrix implant, synthetic, non-antimicrobial
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