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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3M™ ESPE™ Imprint™ 4 Penta™ Super Quick Heavy Intro Kit, 71495
3M Deutschland GmbH
71495
In Commercial Distribution

  • 04035077007801 ()
71495

  • Silicone dental impression material
  • Dental material injection cannula, single-use
  • Dental material mixing nozzle
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ ESPE™ Imprint™ 4 Penta™ Heavy Intro Kit, 71494
3M Deutschland GmbH
71494
In Commercial Distribution

  • 04035077007795 ()
71494

  • Dental impression material adhesive
  • Dental material injection cannula, single-use
  • Dental impression material mixer
  • Silicone dental impression material
  • Dental material mixing nozzle
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
ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
ORGENTEC Diagnostika GmbH
ORG502
Not in Commercial Distribution

  • 04260157080010 ()
ORG502

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
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
"MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis. The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800438
In Commercial Distribution

  • 03661540951886 ()
800438

  • Bordetella pertussis 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. QTY-100@480 reactions.
ELITECH GROUP INC.
800404-100
In Commercial Distribution

  • 03661540952227 ()
800404-100

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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