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 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
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 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)
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