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® 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)
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
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
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)
With over 15 years of tried and true results, the Quickie® TS features traditional tilt-in-space technology and a comprehensive mix of positioning options designed to provide the optimal position for adults.
SUNRISE MEDICAL (US) LLC
TS
In Commercial Distribution

  • 00016958045932 ()
EIZ1A

  • Push-rim manual wheelchair, non-bariatric
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