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® 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)
DYNAMIC MIXING TIPS (50/bag) Type: Penta Type "Red"; For more information: https://www.scottsdental.com/catalog/product/view/id/23795/s/dynamic-penta-type-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8111
In Commercial Distribution

  • D77810481110 ()
  • D77810481111 ()
104-8111

  • Dental material mixing nozzle
CROWN AND BRIDGE MIXING TIP (25/pack) Type: Fine, Ratio: 10:1; For more information: https://www.scottsdental.com/catalog/product/view/id/17354/s/temporary-crown-bridge-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8108
In Commercial Distribution

  • D77810481080 ()
  • D77810481081 ()
104-8108

  • Dental material mixing nozzle
HP MIXING TIPS (48/bag) Color: Purple, Size: Extra Large, 7.5mm; For more information: https://www.scottsdental.com/catalog/product/view/id/23794/s/hp-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8107
In Commercial Distribution

  • D77810481070 ()
  • D77810481071 ()
104-8107

  • Dental material mixing nozzle
HP MIXING TIPS (48/bag) Color: Pink, Size: Medium, 5.4mm; For more information: https://www.scottsdental.com/catalog/product/view/id/23794/s/hp-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8106
In Commercial Distribution

  • D77810481060 ()
  • D77810481061 ()
104-8106

  • Dental material mixing nozzle
HP MIXING TIPS (48/bag) Color: Green/Teal, Size: Large, 6.5mm; For more information: https://www.scottsdental.com/catalog/product/view/id/23794/s/hp-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8104
In Commercial Distribution

  • D77810481040 ()
  • D77810481041 ()
104-8104

  • Dental material mixing nozzle
HP MIXING TIPS (48/bag) Color: Yellow, Size: Small, 4.2mm; For more information: https://www.scottsdental.com/catalog/product/view/id/23794/s/hp-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8105
In Commercial Distribution

  • D77810481050 ()
  • D77810481051 ()
104-8105

  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720803
In Commercial Distribution

  • 00815878022074 ()


  • Dental material mixing nozzle
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013306
In Commercial Distribution

  • 07540172011044 ()

  • cartridge
  • Total Volume: 390 Milliliter
013306

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013301
In Commercial Distribution

  • 07540172011037 ()

  • cartridge
  • Total Volume: 390 Milliliter
013301

  • Silicone dental impression material
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 25 @ 480 reactions.
ELITECH GROUP INC.
800332-25
In Commercial Distribution

  • 03661540952272 ()
800332-25

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV-6 2.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of a total of 2.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a region of the U67 gene."
Elitechgroup Mdx LLC
800499
In Commercial Distribution

  • 03661540951978 ()
800499

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella micadadei. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 105 bp nucleic acid sequence from the ssrA gene region of Legionella micdadei."
Elitechgroup Mdx LLC
M800686
In Commercial Distribution

  • 03661540951213 ()
M800686

  • Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Trichomonas vaginalis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Trichomonas vaginalis. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 67 bp nucleic acid sequence from a repeated DNA fragment in Trichomonas vaginalis."
Elitechgroup Mdx LLC
M800583
In Commercial Distribution

  • 03661540950223 ()
M800583

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
FluoroCore® Starter Pack
DENTSPLY INTERNATIONAL INC.
612310
Not in Commercial Distribution

  • D0026123101 ()

  • Weight: 4.5 Gram
  • 1 syringe base, 1 syringe catalyst, P&B NT (2mL), Self Cure Activator (2mL), Brushes, Mix Tray, and accessories
612310

  • Dental composite resin
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)
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5135
In Commercial Distribution

  • 05060169691070 ()


  • Progesterone IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5130
In Commercial Distribution

  • 05060169690882 ()


  • Progesterone IVD, control
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)
"MGB Alert® Chlamydophila pneumoniae Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Chlamydophila pneumoniae . The mix consists of a total of 7.20 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 80 bp nucleic acid sequence from the Major Outer Membrane Protein gene region of Chlamydophila pneumoniae."
Elitechgroup Mdx LLC
800433
In Commercial Distribution

  • 03661540951763 ()
800433

  • Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Legionella pneumophila Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Legionella pneumophila. The mix consists of a total of 9.00 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 89 bp nucleic acid sequence from the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila.
Elitechgroup Mdx LLC
M800684
In Commercial Distribution

  • 03661540951190 ()
M800684

  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)
longer lengths ideal for self-dispensing or for bulk floss dispensers (sold separately). Choose high-quality, shred-resistant nylon floss, tape or PTFE floss. Mix and match for quantity pricing. 100 yds
PRACTICON, INC.
1000D PTFE MINT
In Commercial Distribution

  • 00723896010488 ()
  • 00723896010471 ()
  • 00723896004630 ()
70-452106

  • Dental floss
longer lengths ideal for self-dispensing or for bulk floss dispensers (sold separately). Choose high-quality, shred-resistant nylon floss, tape or PTFE floss. Mix and match for quantity pricing. 100 yds.
PRACTICON, INC.
1260D/40T MINT TAPE
In Commercial Distribution

  • 00723896010464 ()
  • 00723896010457 ()
  • 00723896004616 ()
70-452104

  • Dental floss
Cleaning solution for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use.
Miris AB
39-04-001
In Commercial Distribution

  • 07350107530034 ()

  • Total Volume: 50 Milliliter
39-04-001

  • Wash/cleaning solution IVD, manual equipment
Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.
Miris AB
39-01-003
In Commercial Distribution

  • 07350107530027 ()

  • Total Volume: 10 Milliliter
39-01-003

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI5.000.05
Not in Commercial Distribution

  • ENTTUTG10MI5000051 ()

  • Diameter: Ø 5,0 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI5.000.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. 25 vials; each 480 reactions.
ELITECH GROUP INC.
800333-25
In Commercial Distribution

  • 03661540952289 ()
800333-25

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. QTY 100 vials @ 480 reactions each.
ELITECH GROUP INC.
800333-100
In Commercial Distribution

  • 03661540952180 ()
800333-100

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert Enterovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm.
Elitechgroup Mdx LLC
M800709
In Commercial Distribution

  • 03661540952111 ()
M800709

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
DSQ Alert Enterovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus.
Elitechgroup Mdx LLC
M800708
In Commercial Distribution

  • 03661540952104 ()
M800708

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the glycoprotein-G gene of HSV-2. The mix consists of a total of 1.44 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 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800588
In Commercial Distribution

  • 03661540952036 ()
M800588

  • Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert HSV-1 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the glycoprotein-D gene of HSV-1. The mix consists of a total of 1.44 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with AquaPhluor 593 and has an excitation wavelength maxima of 593 nm and an emission wavelength maxima of 613 nm.
Elitechgroup Mdx LLC
M800586
In Commercial Distribution

  • 03661540952012 ()
M800586

  • Herpes simplex virus 1 (HSV1) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV-6 2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from the U67 gene of Human herpesvirus 6A (HHV-6A) and Human herpesvirus 6B (HHV-6B). The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "
Elitechgroup Mdx LLC
800500
In Commercial Distribution

  • 03661540951985 ()
800500

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
800434
In Commercial Distribution

  • 03661540951770 ()
800434

  • Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)
"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
800518
In Commercial Distribution

  • 03661540951688 ()
800518

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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