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® 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
"MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect a repeated DNA fragment in Trichomonas vaginalis. 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 and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
M800582
In Commercial Distribution

  • 03661540950209 ()
M800582

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). 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
800423
In Commercial Distribution

  • 03661540951541 ()
800423

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). 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
800404
In Commercial Distribution

  • 03661540951459 ()
800404

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm"
Elitechgroup Mdx LLC
M800687
In Commercial Distribution

  • 03661540951220 ()
M800687

  • Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the macrophage infectivity potentiator (mip) gene region of Legionella pneumophila. The mix consists of one probe at 1.44 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
M800685
In Commercial Distribution

  • 03661540951206 ()
M800685

  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-3 P
Not in Commercial Distribution

  • 04049016053170 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-3 P
Not in Commercial Distribution

  • 04049016053163 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-3 P
Not in Commercial Distribution

  • 04049016053156 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1003-3 P
Not in Commercial Distribution

  • 04049016053149 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
T-MIXER MIXING TIPS (20/pack) Ratio: 1:1, Type: Brown Short; For more information: https://www.scottsdental.com/catalog/product/view/id/23796/s/t-mixer-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8186
In Commercial Distribution

  • D77810481860 ()
  • D77810481861 ()
104-8186

  • Dental material mixing nozzle
T-MIXER MIXING TIPS (20/pack) Ratio: 1:1, Type: Brown Taper; For more information: https://www.scottsdental.com/catalog/product/view/id/23796/s/t-mixer-mixing-tips-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8183
In Commercial Distribution

  • D77810481830 ()
  • D77810481831 ()
104-8183

  • Dental material mixing nozzle
BROWN HUB MIXING TIPS (20/pack) Ratio: 1:1; For more information: https://www.scottsdental.com/catalog/product/view/id/17353/s/temporary-cement-handheld-automix-syringe-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8175
In Commercial Distribution

  • D77810481750 ()
  • D77810481751 ()
104-8175

  • Dental material mixing nozzle
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000319954
In Commercial Distribution

  • 00810000319954 ()


  • Adhesive bandage
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310081
In Commercial Distribution

  • 00810000310081 ()


  • Adhesive bandage
DSQ Alert™ HT Candida auris Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 124 bp region of the ITS2 gene of Candida auris.
Elitechgroup Mdx LLC
M800760
In Commercial Distribution

  • 03661540952562 ()
M800760

  • Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV 1 & 2 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 1.5 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
800416
In Commercial Distribution

  • 03661540951503 ()
800416

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV 1 & 2 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 1.5 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
800354
In Commercial Distribution

  • 03661540951381 ()
800354

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Product Name: Start Kit This product is a customized Start Kit that one content of the kit was replaced with the other product comparing to the ordinary Start Kit. It includes Light Body 1 EA, Heavy Body 1 EA, Putty 1 EA, Yellow Mix Tip 3 EA, Intra Oral Tip 3 EA & Green Mix Tip 3 EA instead of the contents of ordinary Start Kit(NSSK).
NEOSIL Co., Ltd
NSSK-1
In Commercial Distribution

  • 18800026400063 ()
  • 08800026400066 ()


  • Dental impression material kit, single-use
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