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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VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013301
In Commercial Distribution

  • 07540172011037 ()

  • cartridge
  • Total Volume: 390 Milliliter
013301

  • Silicone dental impression material
No Description
BURKHART DENTAL SUPPLY CO., THE
72720803
In Commercial Distribution

  • 00815878022074 ()


  • Dental material mixing nozzle
MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). QTY-100@ 480reactions.
ELITECH GROUP INC.
800350-100
In Commercial Distribution

  • 03661540952203 ()
800350-100

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). QTY-25@ 480reactions.
ELITECH GROUP INC.
800350-25
In Commercial Distribution

  • 03661540952197 ()
800350-25

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
10 gr Syringe, 15 Mixing Tips. Resiment Ready Mix with Fluoride is a high-performance dental resin cement designed for the final cementation of crowns, bridges, implants, and inlays.
STERNGOLD DENTAL LLC
RRM-FL
In Commercial Distribution

  • 00841549118265 ()


  • Dental composite resin
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus
Elitechgroup Mdx LLC
M800726
In Commercial Distribution

  • 03661540952340 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. QTY 100; 480 reactions each.
ELITECH GROUP INC.
800332-100
In Commercial Distribution

  • 03661540952173 ()
800332-100

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-2 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-G gene of HSV-2. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 79 bp region of the glycoprotein-G gene of HSV-2.
Elitechgroup Mdx LLC
M800587
In Commercial Distribution

  • 03661540952029 ()
M800587

  • Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-1 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 9.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 90 bp region of the glycoprotein-D gene of HSV-1.
Elitechgroup Mdx LLC
M800585
In Commercial Distribution

  • 03661540952005 ()
M800585

  • Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® B. pertussis / B. parapertussis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Bordetella pertussis and Bordetella parapertussis. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis."
Elitechgroup Mdx LLC
800437
In Commercial Distribution

  • 03661540951961 ()
800437

  • Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
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