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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Component 4 of 4 of A56123 (Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel)
LIFE TECHNOLOGIES CORPORATION
A56518
In Commercial Distribution

  • 10190302019019 ()
A56123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013386
In Commercial Distribution

  • 07540172017046 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013385

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013381
In Commercial Distribution

  • 07540172017039 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013380

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013380
In Commercial Distribution

  • 07540172000130 ()

  • Total Volume: 380 Milliliter
  • cartridge
013380

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013385
In Commercial Distribution

  • 07540172000147 ()

  • Total Volume: 380 Milliliter
  • cartridge
013385

  • Silicone dental impression material
Aquasil® Ultra+ Regular Set Kit
DENTSPLY INTERNATIONAL INC.
678699
In Commercial Distribution

  • D0026786990 ()

  • 5 Cartridges (50mL), 12 mix tips, 6 I/O tips; 4 small digit (1.6mL) cartridges, 2 large digit (2.4mL) cartridges, 1 syringe dispenser, 6 digit Mix Tips, 6 I/O tips, 1 bottle adhesive (14mL)
678699

  • Silicone dental impression material
"MGB Alert® Enterovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Enterovirus. The mix consists of a total of 1.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the 5’-UTR region of Enterovirus."
Elitechgroup Mdx LLC
800336
In Commercial Distribution

  • 03661540951312 ()
800336

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
Aquasil® Ultra+ digit® LV/XLV Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678033
In Commercial Distribution

  • D0026780331 ()

  • Total Volume: 1.6 Milliliter
  • 4 (1.6mL) small cartridges, 2 (2.4mL) large cartridges, 6 mix tips, 6 intraoral tips, 1 syringe dispenser
  • Total Volume: 2.4 Milliliter
678033

  • Silicone dental impression material
"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). "
Elitechgroup Mdx LLC
800413
In Commercial Distribution

  • 03661540951473 ()
800413

  • 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). "
Elitechgroup Mdx LLC
800350
In Commercial Distribution

  • 03661540951374 ()
800350

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value.
SUNRISE MEDICAL (US) LLC
SR45
In Commercial Distribution

  • 00016958053661 ()
EIZ9

  • Wheelchair, attendant-driven, non-collapsible
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.
Elitechgroup Mdx LLC
800332
In Commercial Distribution

  • 03661540951275 ()
800332

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from hMPV (human Metapneumovirus). The mix consists of a total of 8.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 186 nucleic acid sequence from the Polymerase (L) gene of hMPV."
Elitechgroup Mdx LLC
800306
In Commercial Distribution

  • 03661540951251 ()
800306

  • Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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.
Elitechgroup Mdx LLC
800411
In Commercial Distribution

  • 03661540951466 ()


  • BK virus (BKV) 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)
"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® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800414
In Commercial Distribution

  • 03661540951480 ()
800414

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."
Elitechgroup Mdx LLC
800334
In Commercial Distribution

  • 03661540951299 ()
800334

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV
Elitechgroup Mdx LLC
800348
In Commercial Distribution

  • 03661540951350 ()
800348

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
"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® 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)
"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)
Caulk® Post & Core Kit
DENTSPLY INTERNATIONAL INC.
61i000
Not in Commercial Distribution

  • D00261I0001 ()

  • 15 Fiber Posts 2 Reamers 4 Drills 1 TCGel, 25 Tips, 1 bottle adhesive & activator 1 Mixing Well 2 syringes FluoroCore 10 Mix Tips and Endo Intraoral Tips 1 Mix Pad 30 Paper Points 50 Root Canal Tips
61i000

  • Crown surgical drill bit, reusable
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)
DSQ 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. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800727
In Commercial Distribution

  • 03661540952753 ()


  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ORF 38 region of VZV(Varicella-Zoster Virus). The mix consists of one probe at 0.5 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."
Elitechgroup Mdx LLC
800419
In Commercial Distribution

  • 03661540951527 ()
800419

  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of one probe at 4.96 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.
Elitechgroup Mdx LLC
800349
In Commercial Distribution

  • 03661540951367 ()
800349

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Enterovirus. The mix consists of one probe at 0.14 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.
Elitechgroup Mdx LLC
800337
In Commercial Distribution

  • 03661540951329 ()
800337

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
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